FDA Label for Counteract Childrens Pain Reliever

Otc - Active Ingredient

Active ingredient (in each 5 mL teaspoon)
Acetaminophen 160 mg

Otc - Purpose

Purpose
Pain reliever/fever reducer

Indications & Usage

Use temporarily:

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

Warnings

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
Sore throat warning:  If sore throat is severe, or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

Stop use and ask a doctor if

• 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
These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions

• do not give more than directed (see Liver warning)
• shake well before use
• find right dose on chart. If possible, use weight to dose; otherwise use age.
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor
• this product does not contain directions or complete warnings for adult use

Weight (lb)	Age (yr)	Dose (tsp or mL)
under 24	under 2 years	ask a doctor
24-35	2-3 years	1 tsp or 5 mL
36-47	4-5 years	1 1/2 tsp or 7.5 mL
48-59	6-8 years	2 tsp or 10 mL
60-71	9-10 years	2 1/2 tsp or 12.5 mL
72-95	11 years	3 tsp or 15 mL

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

Storage And Handling

Other information

• store at 20°-25°C (68°-77°F)
  

General Precautions

• each teaspoon contains: sodium 3 mg
• do not use if printed neckband is broken or missing
  

Inactive Ingredient

Inactive ingredients  anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD and C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellusose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Otc - Questions

Questions or comments?
1-800-282-3000