Childrens Acetaminophen

Rij Pharmaceutical Corporation

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL = 1 teaspoon)
• Purpose
• Childrens Acetaminophen Uses
• Warnings
  • Liver warning:
  • Sore throat warning
  • Do not use
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Childrens Acetaminophen Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Childrens Acetaminophen Uses

temporarily:

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

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

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.

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
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• if needed, repeat dose every 4 hours
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor
• only use enclosed measuring cup

Childrens Acetaminophen Other information

• •Store at room temperature 15º - 30ºC (59º - 86ºF)
• •Protect from Freezing.
• •Protect from Light.
• •each teaspoon (5 mL) contains: sodium 7 mg
• • 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, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

PRINCIPAL DISPLAY PANEL