Cough and Sore Throat Daytime description, usages, side effects, indications, overdosage, supplying and lots more!

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Cough and Sore Throat Daytime

Kinray LLC

Cough and Sore Throat Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Purpose

Pain reliever / Fever reducer

Cough suppressant

Cough and Sore Throat Daytime Uses

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

Warnings

Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Acetaminophen or oter pain releivers/ fever reducers.

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 of this product
  • 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 sleep
  • if you are allergic to acetaminophen or any of the ingredients in this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

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

When using this product do not use more than directed

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when 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.

overdose warning: taking more than recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Take only as recommended - see overdose warning
  • use dose cup or Tabelspoon (TBSP) every 6 hours as needed
  • do not exceed 4 doses in 24-hour period

Adults and

children 12 years of age

and over
  • take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed
Children under 12 years
  • do not use this product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage
  • Store at room temperature 15°- 30°C (59° - 86°F)
  • Protect from freezing
  • each tablespoon contains: sodium 21 mg

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

carboxy methyl cellulose sodium, citric acid, FD&C Blue #1, flavor, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol and sucrose

Questions or comments?

1-845-692-5799

Principal Display Panel

Cough and Sore Throat Daytime
Cough & Sore Throat Cough & Sore Throat

Cough and Sore Throat Daytime

Acetaminophen, Dextromethorphan HBr LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61715-076
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
CARBOXYMETHYLCELLULOSE SODIUM
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
MENTHOL
POLYETHYLENE GLYCOLS
propylene glycol
water
SODIUM BENZOATE
saccharin sodium
sorbitol
SUCROSE

Product Characteristics

Color
BLUE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61715-076-08 236 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-08-28


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