INFANTS PAIN RELIEF DYE-FREE- acteaminophen suspension

Infants Pain Relief Dye-Free by

Drug Labeling and Warnings

Infants Pain Relief Dye-Free by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

KEEP OUT OF REACH OF CHILDREN

Uses

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

Warnings

• Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
• more than 5 doses in 24 hours, which is maximum daily amount
• with other drugs containing acetaminophen
• Sore throat warning: if sore throat is severe, persists for more than 2 days, or 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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
• 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

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

• do not give more than directed (see overdose warning)

• shake well before use

• use only enclosed dosing syringe
• find right dose on chart below
• remove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level.
• dispense liquid slowly into childs mouth towards inner cheek
• repeat dose every 4 hours if needed
• do not give more than 5 times in 24 hours
• replace the cap tightly to maintain child resistance
• return dispenser to the box after thorough cleaning

Weight (lb)	Age (yr)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL

* or as directed by a doctor

Other information

• store between 20-25oC(68-77oF)

Inactive ingredients

citric acid anhydrous, butyl paraben, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum

PDP

*Compare to the active ingredient in Childrens TYLENOL®Suspension

Infants Oral Suspension Pain relief

ACETAMINOPHEN 160 mg per 5 mL

PAIN RELIEVER-FEVER REDUCER

Alcohol Free

Aspirin & Ibuprofen Free

For Ages 2-3 Years

Dye-Free

Cherry Flavor

2 FL OZ (60 mL) 160 mg per 5 mL

INGREDIENTS AND APPEARANCE

INFANTS PAIN RELIEF DYE-FREE 
acteaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 50-100 MPA.S AT 1%) (UNII: 6QM647NAYU)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-121-60	1 in 1 CARTON	12/12/2014
1		60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/12/2014

Labeler - WinCo Foods, LLC (056098817)