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ADWE Children’s Pain+Fever Relief


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient (in each 5 mL)

Acetaminophen 160 mg


Purpose

Pain reliever/fever reducer


Uses

  • ▪temporarily:
  • ▪reduces fever
  • ▪relieves minor aches and pains due to: ▪the common cold▪flu▪headache▪sore throat▪toothache

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

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

  • ▪Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • ▪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.
  • ▪if your child is allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease


OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin


OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)


Stop use and ask a doctor if

These could be signs of a serious condition.

  • ▪pain 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

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 24under 2 yearsask a doctor
24-352-3 years5 mL
36-474-5 years7.5 mL
48-596-8 years10 mL
60-719-10 years12.5 mL
72-9511 years15 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

  • ▪very low sodium
  • ▪store at room temperature

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum