Childrens Pain Relief Oral Suspension Grape Flavor

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL =1 teaspoonful)Acetaminophen 160 mg

OTC - PURPOSE SECTION

PurposePain 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

Warnings

liver warningThis product contains acetaminophen. Severe liverdamage may occur if your child takes: ■ more than 5doses in 24 hours, which is the maximum daily amount■ with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skinreactions. Symptoms may include: ■ skin reddening■ blisters ■ rashIf a skin reaction occurs, stop use and seek medicalhelp right away.

Sore throat warningIf 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.

OTC - DO NOT USE SECTION

Do not use■ with any other drug containing acetaminophen(prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctoror pharmacist.■ if your child is allergic to acetaminophen or any ofthe 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 childis taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if■ pain gets worse or lasts more than 5 days ■ fevergets worse or lasts more than 3 days. newsymptoms occur. redness or swelling is present

These could be signs of aserious condition.

Keep out of reach of children.

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warningTaking more than the recommended dose (overdose)may cause liver damage. In case of overdose, getmedical help or contact a Poison Control Center rightaway. (1-800-222-1222) Quick medical attentionis 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 contain directions orcomplete warnings for adult use.■ shake well before using■ mL = milliliter; tsp = teaspoonful■ find right dose on chart below. If possible, useweight to dose; otherwise, use age.■ if needed, repeat dose every 4 hours whilesymptoms last■ do not give more than 5 times in 24 hours■ do not give for more than 5 days unless directedby a doctor.

Weight (Ib)       Age (yr)       Dose (mL or tsp)*under 24          under 2 years      ask a doctor24-35                2-3 years          5 mL (1 tsp)36-47                4-5 years       7.5 mL (1½ tsp)48-59                6-8 years         10 mL (2 tsp)60-71                9-10 year       12.5 mL (2½ tsp)72-95                   11 year          15 mL (3 tsp)

*or as directed by a doctorAttention: use only enclosed dosing cup specificallydesigned for use with this product. Do not use anyother dosing device.

OTHER SAFETY INFORMATION

Inactive ingredients anhydrous citric acid,butylparaben, D&C Red # 33, FD&C Blue # 1, flavor,glycerin, high fructose corn syrup, microcrystallinecellulose and carboxymethylcellulose sodium,propylene glycol, purified water, sodium benzoate,sorbitol solution, sucralose, xanthan gum.

INACTIVE INGREDIENT SECTION

OTC - QUESTIONS SECTION

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