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Cough and Sore Throat Drug Facts


Active ingredients (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg


Purpose

Pain reliever / Fever reducer

Cough suppressant

Antihistamine


Uses

  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing, cough

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:

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.

  • 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

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

Adults and children 12 years of ageand overtake 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed
Children under 12 yearsdo 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
  • 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

Other information

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

  • Store at room temperature 15°- 30°C (59° - 86°F)
  • Protect from freezing
  • each tablespoon contains: sodium 21 mg

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