Label: BABIES R US PAIN AND FEVER- acetaminophen liquid
- NDC Code(s): 51334-161-10, 51334-161-16
- Packager: Toys"R"Us, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 5 mL)
Acetaminophen 160 mgClose
Fever reducer/pain relieverClose
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- sore throat
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 has ever had an allergic reaction to this product or any of its ingredients
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.
- this product does not contain directions or complete warnings for adult use
- 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 syringe designed for use with this product. Do not use any other dosing device.
- remove bottle cap and insert syringe tip through opening at top of the bottle
- tip the bottle upside down and draw medicine into the syringe
- 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 cap tightly to maintain child resistance
under 2 years
ask a doctor
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.Close
- 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, calcium sulfate, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphateClose
- Package/Label Principal Display Panel
Pain & Fever
Acetaminophen - Suspension Liquid
Fever Reducer – Pain Reliever
Use only with enclosed syringe
See New Dosage & Directions
Pediatrician Preferred Dosing System
Compare to the active ingredient of Infants' Tylenol® Suspension Liquid
160 mg per 5 mlClose
- INGREDIENTS AND APPEARANCE
BABIES R US PAIN AND FEVER
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51334-161 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID BUTYLPARABEN CALCIUM SULFATE CARRAGEENAN FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SODIUM PHOSPHATE, TRIBASIC Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51334-161-10 1 in 1 CARTON 1 30 mL in 1 BOTTLE 2 NDC:51334-161-16 1 in 1 CARTON 2 60 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/29/2011 Labeler - Toys"R"Us, Inc. (006985808)