cough and sore throat description, usages, side effects, indications, overdosage, supplying and lots more!

cough and sore throat

Meijer Distribution Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Meijer Distribution, Inc. Cold & Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Purpose

Pain reliever

Cough suppressant

Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoons (3,000 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough 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)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults & children 12 years & over
  • take 2 tablespoons (TBSP) in dose cup provided every 6 hours
  • do not take more than 6 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 25 mg and sodium 8 mg
  • store between 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue #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® Cold & Cough active ingredients

Cool Ice®

Instant Cooling Sensation

SEE NEW WARNINGS AND DIRECTIONS

Cold & Cough

Pain Reliever, Cough Suppressant

Sore Throat/Body Aches/Headache – Acetaminophen

Coughing - Dextromethorphan HBr

DayTime

Principal Display Panel
Cold & Cough Front Label Cold & Cough Back Labels

cough and sore throat

Acetaminophen, Dextromethorphan HBr LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-698
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 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:41250-698-34 237 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-10-26


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