CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

Childrens Dimetapp Multi-Symptom Cold and Flu by

Drug Labeling and Warnings

Childrens Dimetapp Multi-Symptom Cold and Flu by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 ml)	Purposes
Acetaminophen, USP 320 mg	Pain reliever/Fever reducer
Diphenhydramine HCl, USP 12.5 mg	Antihistamine/Cough suppressant
Phenylephrine HCl, USP 5 mg	Nasal decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms associated with a cold, or flu:
  • headache
  • sore throat
  • fever
  • minor aches and pains
• temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • runny nose
• temporarily restores freer breathing through the nose

WARNINGS

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if user takes

• more than 5 doses in any 24-hour period, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• to sedate a child or to make a child sleepy
• in a child under 6 years of age
• if user is now taking a prescription monoamine oxidase 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.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if user has

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if user is

• taking the blood thinning drug warfarin
• taking any other oral nasal decongestant or stimulant
• taking any other pain reliever/fever reducer
• taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

• user gets nervous, dizzy, or sleepless
• pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• new symptoms occur

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• do not take more than 5 doses in any 24-hour period
• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

age	dose
adults and children 12 years and over	20 ml every 4 hours
children 6 to 12 years	10 ml every 4 hours
children under 6 years	do not use

STORAGE AND HANDLING

Other information

• each 10 ml contains: sodium 7 mg
• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

QUESTIONS

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

For most recent product information, visit www.dimetapp.com

SPL UNCLASSIFIED SECTION

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Children's
Dimetapp®

Multi-Symptom
Cold & Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves Nasal Symptoms

• Stuffy Nose
• Runny Nose
• Sneezing

Plus Other Symptoms

• Itchy, Watery Eyes
• Cough
• Fever, Headaches
• Body Aches

Packaged with Tamper-Evident
bottle cap. Do Not Use if breakable
ring is separated or missing.

4 FL OZ (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

NEW FORMULA

Children's
Dimetapp®

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Multi-Symptom
Cold & Flu

Relieves Nasal Symptoms

• Stuffy Nose
• Runny Nose
• Sneezing

Plus Other Symptoms

• Itchy, Watery Eyes
• Cough
• Fever, Headaches
• Body Aches

4 FL OZ (118 ml)
alcohol-free red grape flavor

INGREDIENTS AND APPEARANCE

CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU 
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-2249
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	320 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED (red)	Score
Shape		Size
Flavor	GRAPE (grape)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-2249-04	1 in 1 CARTON	01/01/2020
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2020

Labeler - Wyeth Consumer Healthcare LLC (828831730)