CHILDRENS COUGH PLUS SORE THROAT - acetaminophen and dextromethorphan hydrobromide suspension 
Western Family Foods Inc

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Western Family Children's Cough plus Sore Throat Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Uses

• temporarily relieves the following cold/flu symptoms:
• minor aches and pains
• headache
• sore throat
• cough
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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 who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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.

Ask a doctor before use if your child has

• liver disease
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• do not use more than directed (see Liver warning)
• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise, use age
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• if needed, repeat dose every 4 hours
• do not give more than 5 times in 24 hours

Weight(lb)	Age(yr)	Dose (tsp or mL)
under 36	under 4 years	do not use
36-47	4 to 5 years	1 tsp or 5 mL
48-95	6 to 11 years	2 tsp or 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• each teaspoon contains: sodium 3 mg
• store at 20°-25°C (68°-77°F)
• do not use if printed neckband is broken or missing

Inactive ingredients

carrageenan, citric acid, D&C red no. 33, edetate disodium, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, polysorbate 80, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Principal Display Panel

Children’s Cough Plus Sore Throat

Oral Suspension

Fever Reducer, Pain Reliever, Cough Suppressant

Cherry Flavored

Fever & Sore Throat – Acetaminophen

Cough – Dextromethorphan HBr

See New Warnings Information

Compare to Children’s Tylenol® Plus Cough & Sore Throat active ingredients

CHILDRENS COUGH PLUS  SORE THROAT acetaminophen, dextromethorphan hbr   suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55312-196 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg  in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color RED (opaque) Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 55312-196-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 118 mL In 1 BOTTLE This package is contained within the CARTON (55312-196-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2008

Labeler - Western Family Foods Inc (192166072)

Revised: 01/2010Western Family Foods Inc