Infants Pain Reliever

Rij Pharmaceutical Corporation

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 1.6 mL = 2 droppersful)
• Purpose
• Infants Pain Reliever Uses
• Warnings
  • Liver warning:
  • Sore throat warning
  • Do not use
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Infants Pain Reliever Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Active ingredient (in each 1.6 mL = 2 droppersful)

Acetaminophen 160 mg

Purpose

Fever reducer/ pain reliever

Infants Pain Reliever 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 nonprescription). 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; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems

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 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.
• fill to dose level. Do not use any other dosing device.
• dispense liquid slowly into child's mouth, toward inner cheek.
• if needed, repeat dose every 4 hours while symptoms last.
• do not give use than 5 times in 24 hours
• replace original bottle cap to maintain child resistance
• use only with enclosed dropper
• rinse dropper after each use

Dosing Chart

Attention: Specifically designed for use with enclosed dropper. Use only enclosed dropper to dose this product. Do not use any other dosing devices.

Infants Pain Reliever Other information

• • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
• •shake well before use.
• •Store at room Temperature 15º - 30ºC (59º - 86ºF)
• •protect from freezing.

Inactive ingredients

butyl paraben, cellulose, citric acid, FD&C Blue # 1 FD&C Red # 33, glycerin, high fructose corn syrup, propylene glycol, sodium benzoate, sorbitol, water, xanthan gum

PRINCIPAL DISPLAY PANEL