cough and sore throat

HyVee Inc

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

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each 15 mL = 1 tablespoon)
• Purpose
• cough and sore throat Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• cough and sore throat Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever

Cough suppressant

Antihistamine

cough and sore throat 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 the blood thinning drug warfarin
• •taking sedatives or tranquilizers

When using this product

• •excitability may occur, especially in children
• •may cause marked drowsiness
• •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)

take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed

do not take more than 8 tablespoons  in 24 hours do not use this adult product in children under 12 years of age

•

•

•

adults & children 12 years & over
children under 12 years

cough and sore throat 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

8 FL OZ (237 mL)

cough and sore throat Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID Product Information Product Type Human otc drug label Item Code (Source) NDC:42507-666 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM FD&C BLUE NO. 1 POLYETHYLENE GLYCOLS propylene glycol water SODIUM BENZOATE sorbitol SUCROSE Product Characteristics Color BLUE (clear) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-666-34 237 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2008-07-20