babies r us infants pain relief description, usages, side effects, indications, overdosage, supplying and lots more!

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babies r us infants pain relief

Toys"R"Us, Inc.

Toys "R" Us, Inc Infants' Pain Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

babies r us infants pain relief Uses

temporarily:

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

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

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 present

These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dropper designed for use with this product. Do not use any other dosing device.
  • fill to dose level
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • 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 unless directed by a doctor
  • replace dropper tightly to maintain child resistance
  • this product does not contain directions or complete warnings for adult use
Dosing Chart
Weight(lb) Age(yr) Dose (mL)
under 24 under 2 years ask a doctor
24-35 2–3 years 1.6 mL (0.8 + 0.8 mL)

Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

Other information

  • store at 20°-25°C (68°-77°F)
  • do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Infants’ Pain Relief

Acetaminophen

Concentrated Drops

Fever Reducer – Pain Reliever

Aspirin Free

Ibuprofen Free

Alcohol Free

Cherry Flavor

Use only with enclosed dropper

See New Warnings Information

Compare to the active ingredient of Concentrated Tylenol® Infants’ Drops

80 mg per 0.8 mL

babies r us infants pain relief
Infant's Pain Relief Carton Image 1 Infant's Pain Relief Carton Image 2

babies r us infants pain relief

Acetaminophen SUSPENSION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51334-008
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
propylene glycol
water
SODIUM BENZOATE
sorbitol

Product Characteristics

Color
RED (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, DROPPER
2 15 in 1 BOTTLE, DROPPER
3 NDC:51334-008-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-12-01


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Be sure to consult your doctor before taking any medication!
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