FDA Label for Childrens Acetaminophen

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

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 non-prescription). 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

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 - When Using

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

Stop Use And Ask A Doctor If

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use.
• shake well before using
• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor

Weight (lb.)      Age(yrs.)      Dose (mL*)

Under 24           Under 2       Ask a doctor

24-35                  2-3                 5 mL

36-47                  4-5                 7.5 mL

48-59                  6-8                 10 mL

60-71                  9-10               12.5 mL

72-95                  11                  15 mL

* always check with your doctor before administering medicine to your infant/child

Other Information

• each teaspoon (5 mL) contains: sodium 7 mg
• Store at room temperature 15° - 30°C (59° - 86°F)
• Protect from Freezing.
• Protect from Light.
• TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive Ingredients

citric acid, FD&C red # 40, FD&C blue # 1, flavor, glycerin. PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions Or Comments

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

*Compare to the active ingredient in Children's Tylenol® Elixir

Children's Acetaminophen Elixir
Grape Flavor
For ages 2 to 11
2 FL OZ (60 mL)