FDA Label for Acetaminophen Infants

Active Ingredient (In Each 0.8 Ml)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

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

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.

Ask A Doctor Before Use If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin

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.

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.

Directions

• do not give more than directed (see Liver warning)
• shake well before using
• find right dose on chart. If possible, use weight to dose; otherwise use age.
• use only enclosed dropper designed for use with this product. Do not use any other dosing device.
• fill to dose level
• dispense liquid slowly into child’s mouth, toward inner cheek
• 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
• replace dropper tightly to maintain child resistance
• this product does not contain directions or complete warnings for adult use

Dosing Chart
Weight(lb)	Age(yr)	Dose (mL)
under 24	under 2 years	ask a doctor
24-35	2–3 years	1.6 mL (0.8 + 0.8 mL)

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

Other Information

• store at 20°-25°C (68°-77°F)
• do not use if printed bottle wrap is broken or missing

Inactive Ingredients

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

Questions Or Comments?

1-800-719-9260

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Acetaminophen Infant Drops

Fever Reducer -Pain Reliever

Use Only with Enclosed Dropper

Cherry Flavor - Alcohol-Free - Aspirin-Free - Ibuprofen-Free

80 mg per 0.8 mL

Infants' Pain Relief Concentrated Drops package label - 3267