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good sense cough and sore throat

L Perrigo Company

Perrigo Cough and Sore Throat Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Purpose

Pain reliever

Cough suppressant

good sense cough and sore throat Uses

  • temporarily relieves:
  • minor aches and pains
  • headache
  • sore throat
  • cough due to a cold

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.

Ask a doctor before use if you have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

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
  • 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

Pain Relief

See New Warnings Information

Cough & Sore Throat

Sore Throat

Headache

Body Aches

Coughing

DayTime

Non-Drowsy

Pain Reliever

Cough Suppressant

Acetaminophen

Dextromethorphan HBr

Cool Ice®

Instant Cooling Sensation

Compare to active ingredients of Tylenol® Cough & Sore Throat

good sense cough and sore throat
Cough and Sore Throat Label Front Cough and Sore Throat Label Back

good sense cough and sore throat

Acetaminophen, Dextromethorphan HBr LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0113-0698
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

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)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0113-0698-34 237 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-02-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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