Dexbrompherniramine Maleate and Pseudoephedrine Sulfate

Manufacturer: KVK-TECH, INC. | AVANTHI | KVK-TECH, INC
Effective date: 2017-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:57:42

Label at a glance#

ProductDexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg

Active ingredientDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE SULFATE

Label structure13 sections

Dosage and administration

adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: ask a doctor each tablet contains: calcium 69 mg and sodium 0 mg store between 20° to 25°C (68° to 77°F) protect from excessive moisture

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA 1088

PhoneLabel contact1-215-579-1842

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Dexbrompheniramine maleate 6 mg

Pseudoephedrine Sulfate 120 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

USES

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and associated with sinusitis
helps decongest sinus openings and sinus passages
reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
temporarily alleviates the following symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itching of the nose or throat
- itchy and watery eyes

WARNINGS

WARNINGS SECTION

Do not use If you are now taking a prescription monoamineoxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedative or tranquilizers

WHEN USING THIS PRODUCT

INDICATIONS & USAGE SECTION

do not use more than directed
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

You may report side effects to FDA at 1-800-FDA 1088

IF PREGNANT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: ask a doctor

OTHER INFORMATION

each tablet contains: calcium 69 mg and sodium 0 mg
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

calcium sulfate, carnauba wax, colloidal silicon dioxide, D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake, FD&C yellow No. 6 aluminum lake, gelatin, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, pregelatinized maize starch, propyl parahydroxy benzoate, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

QUESTIONS

call 1-215-579-1842

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Dexbrompheniramine Maleate 6 mg

and Pseudoephedrine Sulfate 120 mg

Extended-release Tablets

Antihistamine/Nasal Decongestant

COLD & ALLERGY

Maximum Strength

Nasal & Sinus Congestion
Runny Nose, Sneezing
Itchy, Watery Eyes
12 Hour Sustained Relief

20 EXTENDED-RELEASE TABLETS

SAFETY SEALED: DO NOT USE IF BACKING ON BLISTER CARD IMPRINTED WITH DEXBROMPHENIRAMINE MALEATE 6 mg AND PSEUDOEPHEDRINE SULFATE 120 mg IS TORN OR MISSING.

Manufactured by KVK-TECH, INC.

Newtown, PA18940 MADE IN USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label

Dexbrompheniramine Maleate 6 mg
and Pseudoephedrine Sulfate 120 mg
Extended-release Tablets

Antihistamine/Nasal Decongestant

COLD & ALLERGY

Maximum Strength

Nasal & Sinus Congestion
Runny Nose, Sneezing
Itchy, Watery Eyes12 Hour Sustained Relief

20 EXTENDED-RELEASE TABLETS

carton label

Container Label

NDC 10702-005-03

Dexbrompheniramine Maleate 6 mg
and Pseudoephedrine Sulfate 120 mg
Extended-release Tablets

Antihistamine/Nasal Decongestant

COLD & ALLERGY

Maximum Strength

Nasal & Sinus Congestionunny Nose, Sneezing
Itchy, Watery Eyes12 Hour Sustained Relief

30 EXTENDED-RELEASE TABLETS

DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING.

container Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-005	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	4	Legacy NDC	20181217_cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	2
PSEUDOEPHEDRINE SULFATE	ACTIVE INGREDIENT	Y9DL7QPE6B	2
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg
Dexbrompherniramine Maleate and Pseudoephedrine Sulfate
DEXBROMPHENIRAMINE MALEATE
DEXBROMPHENIRAMINE
PSEUDOEPHEDRINE SULFATE
PSEUDOEPHEDRINE
CALCIUM SULFATE
CARNAUBA WAX
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
METHYLPARABEN
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POVIDONE
STARCH, CORN
PROPYLPARABEN
SODIUM BENZOATE
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10702-005	10702-005-21, 10702-005-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXBROMPHENIRAMINE MALEATE	BPA9UT29BS	ACTIB
PSEUDOEPHEDRINE SULFATE	Y9DL7QPE6B	ACTIB
CALCIUM SULFATE	WAT0DDB505	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 15 · 848 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / RECTAL		315 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / SUBCUTANEOUS		98 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	PELLET / ORAL		640 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAMUSCULAR		150 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	GRANULE, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	LOTION / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SYSTEM / TOPICAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE PELLETS / ORAL		147 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	ELIXIR / ORAL	0.3 mg/15ml		Exact identifier — unii candidate 31 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTILLE / ORAL	143 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2013-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
43557417-acc5-3e0e-e063-6294a90aaaaa			cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4	2025-11-11	Warnings	Exact identifier spl set id: cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.