Infants' Pain Relief Oral Suspension Grape Flavor

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)    Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose    Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses temporarily:

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

WARNINGS SECTION

WarningsLiver warning: This product contains acetaminophen. Severeliver damage may occur if your child takes■ more than 5 doses in 24 hours, which is the maximum dailyamount■ with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skinreactions. Symptoms may include:■ skin reddening. blisters. rash.If askin reaction occurs, stop use and seek medical help rightaway.

Sore throat warning: if sore throat is severe, persists for morethan 2 days, is accompanied or followed by fever, headache,rash, nausea, or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use■ with any other drug containing acetaminophen (prescriptionor nonprescription). If you are not sure whether adrugcontains acetaminophen, ask a doctor or pharmacist■ if your child is allergic to acetaminophen or any of theinactive 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 takingthe blood thinning drug warfarin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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 presentThese could be signs of a serious condition.

Keep out of reach of children

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warningIn case of overdose, get medical help or contact a PoisonControl Center right away. (1-800-222-1222) Quick medicalattention is critical for adults as well as for children even if youdo not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions■ this product does not containdirections or complete warnings foradult use.■ shake well before using■ mL = milliliter■ find right dose on chart below. If   possible, use weight to dose;   otherwise, use age.■ 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

*or as directed byAttention: use only enclosed dosingsyringe specifically designed for usewith this product. Do not use any otherdosing device.

OTHER SAFETY INFORMATION

Other information■ each 5 ml contains: sodium 3 mg■ store between 20-25°C (68-7TF)■ do not refrigerate

INACTIVE INGREDIENT SECTION

Inactive ingredientsanhydrous citric acid, butylparaben,D&C Red # 33, FD&C Blue # 1, flavor,glycerin, high fructose corn syrup,microcrystalline cellulose andcarboxymethylcellulose sodium,propylene glycol, purified water, sodiumbenzoate, sorbitol solution, sucralose,xanthan gum.

OTC - QUESTIONS SECTION

Questions? Call weekdays from 9:30AM to 4:30 PM EST at 1-877-798-5944