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CVS Health Children's COLD + Cough & Runny Nose


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - PURPOSE SECTION

Acetaminophen 160 mgPain reliever/fever reducer
Chlorpheniramine maleate 1 mgAntihistamine
Dextromethorphan HBr 5 mgCough suppressant

Uses

  • •temporarily relieves the following cold/flu symptoms:•minor aches and pains•headache•sore throat•sneezing and runny nose•cough
  • •temporarily reduces fever

Warnings


Liver warning:

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

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

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

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

  • •skin reddening
  • •blisters
  • •rash

SPL UNCLASSIFIED SECTION

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.
  • •to make a child sleepy
  • •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.
  • •if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

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

Ask a doctor or pharmacist before use if your child is

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

When using this product

  • •do not exceed recommended dose (see overdose warning)
  • •marked drowsiness may occur
  • •sedatives and tranquilizers may increase drowsiness
  • •excitability may occur, especially in children

Stop use and ask a doctor if

These could be signs of a serious condition.

  • •pain or cough gets worse or lasts more than 5 days
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •redness or swelling is present
  • •cough comes back or occurs with rash or headache that lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

under 36under 4 yearsdo not use
36-474 to 5 yearsdo not use unless directed by a doctor
48-956 to 11 years10 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
  • •mL = milliliter
  • •find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • •remove the child protective cap and squeeze your child's dose into the dosing cup
  • •repeat dose every 4 hours, while symptoms last
  • •do not give more than 5 times in 24 hours

Other information

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

  • •each 5 mL contains: sodium 3 mg
  • •store at room temperature

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum