INFANTS PAIN RELIEF- acetaminophen liquid

Infants Pain Relief by

Drug Labeling and Warnings

Infants Pain Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium (Premier Value), davAgen Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purposes

Pain reliever/fever reducer

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, persist 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 is taking the blood thinning drug warfarin.

Ask a Doctor before use if your child has liver disease.

When using this product do not exceed recommended dosage (see overdose warning)

Stop use and ask a doctor if

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

These could be signs of a serious condition.

Keep this and all drugs out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222). 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. If possible, use weight to dose; otherwise use age.
• use only the enclosed syringe designed for use with this product. Do not use any other dosing device.
• remove bottle cap and insert syringe into hole at top of bottle and turn upside down.
• pull back plunger of syringe until syringe filled slightly over prescribed level.

Turn to original position, simply push plunger back until you have reached the prescribed level. Pull syringe out of the bottle.

• dispense liquid slowly into baby's mouth, toward the inner cheek.
• if needed repeat dose every 4 hours while symptoms last.
• do not use more than 5 times in 24 hours (see overdose warning).
• replace cap tightly to maintain child resistance.

Dosing Chart

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

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

Other information

• store at controlled room temperature
• each 5 mL contains: sodium 2 mg

Inactive ingredients

Carboxymethylcellulose, Flavor, Glycerin, High Fructose Corn Syrup, Methyl Paraben, Microcrystal Cellulose, Polyethylene Glycol 1450, Propyl Paraben, Propylene Glycol, Purified Water, Saccharin Sodium, Sorbitol, Sucralose, Xanthan Gum

Questions or comments?

1-732-249-6363

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DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

NDC: 68016-160-02

Premier
Value ®

Infants'
Pain Relief

PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN

SUSPENSION LIQUID
  Dye Free
  Alcohol Free
  Aspirin Free

Use only with
enclosed syringe

Cherry Flavor

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

INFANTS PAIN RELIEF 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-160
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
Xanthan Gum (UNII: TTV12P4NEE)
Carboxymethylcellulose (UNII: 05JZI7B19X)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Sucralose (UNII: 96K6UQ3ZD4)
Saccharin Sodium (UNII: SB8ZUX40TY)
Propylene Glycol (UNII: 6DC9Q167V3)
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)
High Fructose Corn syrup (UNII: XY6UN3QB6S)
Glycerin (UNII: PDC6A3C0OX)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-160-02	1 in 1 CARTON
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	10/03/2014

Labeler - Chain Drug Consortium (Premier Value) (101668460)

Registrant - davAgen Pharmaceutical, LLC (967545935)

Establishment
Name	Address	ID/FEI	Business Operations
davAgen Pharmaceutical, LLC		967545935	MANUFACTURE(68016-160) , PACK(68016-160) , LABEL(68016-160) , ANALYSIS(68016-160)