COUGH AND SORE THROAT PAIN RELIEF - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid 
HyVee Inc

----------

Hy-Vee, Inc. Cough & Sore Throat Drug Facts

Active ingredient (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever

Cough suppressant

Antihistamine

Uses

• temporarily relieves the following cold/flu symptoms:
• minor aches and pains
• headache
• sore throat
• runny nose and sneezing
• cough

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4 doses in 24 hours, 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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are 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.
• to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 7 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.

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. (1-800-222-1222) Quick 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 directed (see Liver warning)

adults and children 12 years and over	take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed do not take more than 8 tablespoons in 24 hours
children under 12 years	do not use this adult product in children under 12 years of age

Other information

• each tablespoon contains: potassium 20 mg and sodium 8 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Cough & Sore Throat Nighttime Liquid active ingredients

See New Warnings Information

Pain Relief

Cough & Sore Throat

Pain Reliever, Cough Suppressant, Antihistamine

Night Time

Cool Ice®

Instant Cooling Sensation

Contains 3 Medicines:

Sore Throat, Body Aches/Headache – Acetaminophen

Coughing – Dextromethorphan HBr

Runny Nose – Doxylamine Succinate

COUGH AND SORE THROAT  PAIN RELIEF acetaminophen, dextromethorphan hbr, doxylamine succinate   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 42507-666 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg  in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 15 mL DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg  in 15 mL

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM   ANHYDROUS CITRIC ACID   CARBOXYMETHYLCELLULOSE SODIUM   FD&C BLUE NO. 1   POLYETHYLENE GLYCOL   PROPYLENE GLYCOL   WATER   SODIUM BENZOATE   SORBITOL   SUCROSE

Product Characteristics Color BLUE (clear) Score      Shape Size Flavor MENTHOL Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42507-666-34 237 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/20/2008

Labeler - HyVee Inc (006925671)

Revised: 08/2009HyVee Inc