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American Sales Company Children’s Multi-Symptom Fever & Cold Drug Facts


Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg


Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant


Uses

  • •temporarily relieves
  • •minor aches and pains
  • •headache
  • •minor sore throat pain
  • •runny nose
  • •itchy nose or throat
  • •sneezing
  • •itchy, watery eyes due to hay fever
  • •nasal and sinus congestion
  • •cough due to minor throat and bronchial irritation as may occur with a cold
  • •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

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 5 doses in 24 hours, which is the maximum daily amount
  • •with other drugs containing acetaminophen

Do not use

  • •in a child under 4 years of age
  • •if your child has ever had an allergic reaction to this product or any of its ingredients
  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • •in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • •to make a child sleepy

Ask a doctor before use if the child has

  • •liver disease
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •glaucoma
  • •a breathing problem such as chronic bronchitis
  • •cough that occurs with too much phlegm (mucus)
  • •persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if the child is

taking

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

When using this product

  • •do not exceed recommended dosage
  • •marked drowsiness may occur
  • •sedatives and tranquilizers may increase drowsiness
  • •excitability may occur, especially in children

Stop use and ask a doctor if

  • •nervousness, dizziness or sleeplessness occur
  • •pain, nasal congestion or cough gets worse or lasts more than 5 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.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.


Directions

AgeDose
children under 4 years of agedo not use
children 4 to under 6 years of agedo not use unless directed by a doctor
children 6 to under 12 years of age10 mL
  • •this product does not contain directions or complete warnings for adult use
  • •do not give more than directed (see Overdose warning)
  • •shake well before using
  • •remove the child protective cap and squeeze your child’s dose into the dosing cup
  • •may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
  • •use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.

Other information

  • •each 5 mL contains: sodium 3 mg
  • •contains no aspirin
  • •store at 20-25°C (68-77°F). Protect from light.
  • •close cap tightly

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum