CHILDRENS DIMETAPP FEVER AND SORE THROAT - acetaminophen liquid
Richmond Division of Wyeth

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT (IN EACH 5 ML TSP)

Acetaminophen, USP 160 mg

PURPOSE

Pain reliever/Fever reducer

USES

temporarily relieves these symptoms associated with a cold, or flu:
- headache
- sore throat
- minor aches and pains
temporarily reduces fever

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
taken with other drugs containing acetaminophen
adult takes 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

in a child under 2 years of age

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

Ask a doctor before use if user has

liver disease

Ask a doctor or pharmacist before use if user is

taking the blood thinning drug warfarin
taking any other pain reliever/fever reducer

When using this product

do not use more than directed

Stop use and ask a doctor if

pain gets worse or lasts more than 5 days (children) or 10 days (adults)
fever gets worse or lasts more than 3 days
redness or swelling is present
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.

age	dose
12 years and over	4 teaspoons every 4 hours
6 to under 12 years	2 teaspoons every 4 hours
4 to under 6 years	1 1/2 teaspoons every 4 hours
2 to under 4 years	1 teaspoon every 4 hours
under 2 years	do not use

OTHER INFORMATION

each teaspoon contains: sodium 4 mg and potassium 5 mg
store at 20-25°C (68-77°F)
dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, glycerin, high fructose corn syrup, menthol, natural flavor, polyethylene glycol, propylene glycol, purified honey, purified water, sodium benzoate, sodium citrate, sucralose

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

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

NEW

Children’s Dimetapp Fever & Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

For Ages 2 Years & Older

Natural Grade ‘A’ Honey

Relieves

Fever
Sore Throats
Minor Aches & Pains
Headaches

For Ages 2 Yrs. & Over

4 FL OZ (118 ml)

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

We pledge to you that Dimetapp products contain only high quality ingredients and meet strict standards of quality and safety. You can trust Dimetapp products for your family.

Dosing cup to be used with Children’s Dimetapp Fever & Sore Throat only.

Pfizer

Pfizer, Madison, NJ 07940 USA

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

Children's Dimetapp Fever and Sore Throat Packaging

CHILDRENS DIMETAPP FEVER AND SORE THROAT
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0031-2201
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (acetaminophen)	acetaminophen	160 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid
glycerin
high fructose corn syrup
honey
menthol
polyethylene glycol
propylene glycol
sodium benzoate
sodium citrate
sucralose
water

Product Characteristics
Color	YELLOW (translucent, golden-amber liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains	4 mg sodium, 5 mg potassium (4 mg sodium, 5 mg potassium)

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0031-2201-13	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		118 mL in 1 BOTTLE	This package is contained within the CARTON (0031-2201-13)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	06/15/2011

Labeler - Richmond Division of Wyeth (829390827)

Establishment
Name	Address	ID/FEI	Operations
Richmond Division of Wyeth		829390827	MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 06/2011 Richmond Division of Wyeth