Dologen

Manufacturer: Kramer Novis
Effective date: 2018-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:58:01

Label at a glance#

ProductDologen

Active ingredientDEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN

Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor pain of arthritis • relieves runny nose, and sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies. Temporarily reduces fever.

Dosage and administration

Adults and children 12 years of age and older: take 1 caplet every 4 - 6 hours or as directed by a doctor Do not exceed 6 caplets in 24 hours Children under 12 years : Consult a doctor

Storage and handling

• Tamper Evident. Do not use if seal is broken. • Store at controlled room temperature 15° to 30°C (59° to 86°F). • Avoid excessive heat and humidity.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(787) 767-2072

Websitewww.kramernovis.com

www.kramernovis.com

Label contents#

Full prescribing information#

Active Ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dexbrompheniramine Maleate 2 mg

Purpose

OTC - PURPOSE SECTION

Analgesic, Antipyretic (Fever Reducer)

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

Warnings

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 caplets (3,900 mg) in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash. If skin reaction occurs, stop use and seek medical help right away.

Do not use : with any other product containing acetaminophen (prescription or nonprescription), this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. When using this product do not exceed recommended dose.

Ask a doctor before use if you have: •liver disease • breathing problems such as emphysema or chronic bronchitis • glaucoma or difficulty in urination due to enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are taking: • the blood thinning drug warfarin • sedatives or tranquilizers

While using this product:• excitability may occur • drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if: • pain gets worse or lasts for more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION


Adults and children 12 years of age and older:	take 1 caplet every 4 - 6 hours or as directed by a doctor Do not exceed 6 caplets in 24 hours
Children under 12 years : Consult a doctor

Other Information:

STORAGE AND HANDLING SECTION

• Tamper Evident. Do not use if seal is broken.

• Store at controlled room temperature 15° to 30°C (59° to 86°F). • Avoid excessive heat and humidity.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

corn starch, hydroxypropylmethylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and stearic acid

SPL UNCLASSIFIED SECTION

Pain Reliever

Fever Reducer

Antihistamine

Sugar & Dye Free

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072

www.kramernovis.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1190931	Acetaminophen/Dexbrompheniramine (Oral Pill)	acetaminophen 650 MG / dexbrompheniramine maleate 2 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1190931	acetaminophen 650 MG / dexbrompheniramine maleate 2 MG Oral Tablet	PSN	4
1190931	acetaminophen 650 MG / dexbrompheniramine maleate 2 MG Oral Tablet	SCD	4
1190931	APAP 650 MG / Dexbrompheniramine maleate 2 MG Oral Tablet	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-481-02	2023-01-30	C162847	48780-1	f386c64a-0c67-0266-e053-dadaa90a7c1a	Dologen
52083-481-90	2023-01-30	C162847	48780-1	f386c64a-0c67-0266-e053-dadaa90a7c1a	Dologen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-481-02	Dologen	2 in 1 PACKET	TABLET	2		4
52083-481-90	Dologen	90 in 1 BOTTLE	TABLET	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-481	DOLOGEN (DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN) TABLET [KRAMER NOVIS]	4	Legacy NDC, 2 package rows	20181231_f8490040-51cd-4825-aea7-09a618437d29.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-481-90	EA - Each	52083-481	635fb43c-f052-4ab9-942f-f24193c56862	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	1
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	1
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Dologen
Dexbrompheniramine Maleate, Acetaminophen
DEXBROMPHENIRAMINE MALEATE
DEXBROMPHENIRAMINE
ACETAMINOPHEN
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52083-481	52083-481-90, 52083-481-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXBROMPHENIRAMINE MALEATE	BPA9UT29BS	ACTIB
ACETAMINOPHEN	362O9ITL9D	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML · Source PDF

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 3 · 165 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, CHEWABLE / ORAL		245 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SUSPENSION / OPHTHALMIC		14 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SYSTEM / TRANSDERMAL		15 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	INJECTION / INTRAMUSCULAR	0.59 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, DELAYED RELEASE PELLETS / ORAL		178 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / SUBLINGUAL		30 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	POWDER, FOR SOLUTION / ORAL		2832 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, FILM COATED / ORAL		245 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	POWDER / ORAL		378 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	45 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TROCHE / ORAL		175 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, LIQUID FILLED / ORAL		101 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	PELLET / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SOLUTION / OPHTHALMIC		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, EXTENDED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 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

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
ddc31276-446c-42f4-9558-04c7c6bff944			f8490040-51cd-4825-aea7-09a618437d29	2018-12-29	Warnings	Exact identifier spl id: ddc31276-446c-42f4-9558-04c7c6bff944 spl set id: f8490040-51cd-4825-aea7-09a618437d29

Reported adverse events (FAERS/openFDA)#

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