Pediatric Cough and Cold Medicine

Manufacturer: Lannett Company, Inc.
Effective date: 2014-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: legacy-cache
Hydrated at: 2026-08-02 01:02:59

Label at a glance#

ProductPediatric Cough and Cold Medicine

Active ingredientCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE

Label structure9 sections

Dosage and administration

Dose may be repeated every 4 to 6 hours or as directed by a doctor Do not exceed 4 doses in 24 - hour period. AGE DOSE Children 6 to under 11 years 2 teaspoonfuls (TSP) Children under 6 years DO NOT USE

Contacts and useful links#

PhoneLabel contact888-974-5279

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Chlorpheniramine maleate 1 mg (in each 5 mL)

Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL)

Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL)

OTC - PURPOSE SECTION

Purpose of Chlorpheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Purpose of Dextromethorphan hydrobromide: Cough Suppressant

INDICATIONS & USAGE SECTION

Uses temporarily relieves common cold, hay fever or other upper respiratory allergy symptoms:

nasal congestion
runny nose
sneezing
cough

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has

heart diseases
high blood pressure
thyroid disease
diabetes
glaucoma
asthma
a breathing problem or a persistent or chronic cough
excessive phlegm (mucus)
cough that occurs with too much phlegm (mucus)
chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product your child may

become easily excited
get drowsy
sedatives, and tranquilizers may increase drowsiness

OTC - STOP USE SECTION

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Dose may be repeated every 4 to 6 hours or as directed by a doctor
Do not exceed 4 doses in 24 - hour period.

AGE	DOSE
Children 6 to under 11 years	2 teaspoonfuls (TSP)
Children under 6 years	DO NOT USE

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature 20°-25°C (68°-77°F). Do not use if tamper-evident band around cap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red no. 40, wild cherry flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol.

Questions

OTC - QUESTIONS SECTION

888-974-5279

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1117392	chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution	chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD Active

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-115-40	ML - Milliliter	54838-115	1152ae5a-56ee-4cee-a697-5da6ac3c4e9d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Chlorpheniramine maleate	ACTIVE INGREDIENT	V1Q0O9OJ9Z	12
Dextromethorphan hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	12
Pseudoephedrine hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	12
Chlorpheniramine	ACTIVE MOIETY	3U6IO1965U	12
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	12
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	12
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	12
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	12
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	12
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	12
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	12
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	12
sorbitol	INACTIVE INGREDIENT	506T60A25R	12
water	INACTIVE INGREDIENT	059QF0KO0R	12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Pediatric Cough and Cold Medicine
Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM CITRATE
SORBITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54838-115	54838-115-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHLORPHENIRAMINE MALEATE	V1Q0O9OJ9Z	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	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 6 · 324 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / SUBLINGUAL		11 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	OIL / TOPICAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LOTION / TOPICAL		211 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / BUCCAL		9 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SUSPENSION / ORAL		570 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION/ DROPS / AURICULAR (OTIC)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 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
53c2be18-f690-4d71-badd-6d886ba126b9			ba807ce6-2ef4-4fd9-b312-beeaefe56c97	2014-06-25	Warnings	Exact identifier spl set id: ba807ce6-2ef4-4fd9-b312-beeaefe56c97

Reported adverse events (FAERS/openFDA)#

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