Label: INFANTS PAIN RELIEF ORAL SUSPENSION GRAPE FLAVOR- acetaminophen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-242-02 - Packager: Pharmacy Value Alliance, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 24, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 acetaminophenAllergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
■ skin reddening. blisters. rash.
If askin reaction occurs, stop use and seek medical help right
away.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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- Keep out of reach of children
- OVERDOSAGE
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DOSAGE & ADMINISTRATION
Directions
■ this product does not contain
directions or complete warnings for
adult use.
■ shake well before using
■ mL = milliliter
■ find right dose on chart below. If
possible, use weight to dose;
otherwise, use age.
■ 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 daysDosing Chart Weight (lb) Age (yr) Dose (mL)* Under 24 Under 2 years Ask a doctor 24 - 35 2 -3 years 5 mL *or as directed by
Attention: use only enclosed dosing
syringe specifically designed for use
with this product. Do not use any other
dosing device. - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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Principal Display Panel
Premier
Value®
Infants'
Pain Relief
PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
ORAL SUSPENSION
Grape Flavor
Premier
Value®
Compare to Infants'
TYLENOL® Oral Suspension
active ingredient**
Infants'
Pain Relief
PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
- Alcohol Free
- Aspirin Free
- Ibuprofen Free
Use ONLY
enclosed syringeGrape
Flavor
2 FL OZ (59 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDLOT:
EXP:
DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING
BX-077
DISTRIBUTED BY:
PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE,
WAYNE, PA 19087**This product is not manufactured or distributed by
McNeil Consumer Healthcare, distributor of Infants'
Tylenol® Oral Suspension.IMPORTANT INSTRUCTIONS
1 Remove the cap.
2 Insert the syringe
tip through the
opening at the
top of the bottle.3 Turn the bottle
upside down and
fill syringe to
dose.Use enclosed
syringe only.Do not use other
dosing devices.INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDIf for any reason you are not satisfied
with this product, please return it to the
store where purchased for a full refund.Product Label - Outer
Product Label - Inner
Premier Value® Infants' Pain Relief
end res
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INGREDIENTS AND APPEARANCE
INFANTS PAIN RELIEF ORAL SUSPENSION GRAPE FLAVOR
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-242 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) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-242-02 1 in 1 CARTON 10/01/2018 1 59 mL in 1 BOTTLE; 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 10/01/2018 Labeler - Pharmacy Value Alliance, LLC (101668460)