Childrens Dimetapp Multi-Symptom Cold and Flu: Package Insert and Label Information

CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredients (in each 10 ml)

Acetaminophen, USP 320 mg

Diphenhydramine HCl, USP 12.5 mg

Phenylephrine HCl, USP 5 mg

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

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

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.

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

Other information

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

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 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

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 Label
(click image for full-size original)

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

Principal Display Panel -- 118 ml Bottle Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 320 mg in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
GLYCERIN
MENTHOL, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYL GALLATE
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
SUCRALOSE
Product Characteristics
Color RED (red) Score
Shape Size
Flavor GRAPE (grape) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0031-2249-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (0031-2249-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2020 08/31/2022
Labeler — GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 06/2021 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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