FDA Label for Infants Pain Relief Oral Suspension Grape Flavor
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
Infants Pain Relief Oral Suspension Grape Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each 5 mL) Acetaminophen 160 mg
Otc - Purpose
Purpose Pain reliever/fever reducer
Indications & Usage
Uses temporarily:
■ reduces fever
■ relieves minor aches and pains due to:
■ the common cold ■ flu ■ headache ■ sore throat
■ toothache
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 acetaminophen
Allergy 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.
Otc - Do Not Use
Do not use
■ with any other drug containing acetaminophen (prescription
or nonprescription). If you are not sure whether adrug
contains acetaminophen, ask a doctor or pharmacist
■ if your child is allergic to acetaminophen or any of the
inactive ingredients in this product.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking
the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose
(see overdose warning)
Otc - Stop Use
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
Keep out of reach of children.
Overdosage
Overdose warning
In case of overdose, get medical help or contact a Poison
Control Center right away. (1-800-222-1222) Quick medical
attention is critical for adults as well as for children even if you
do not notice any signs or symptoms.
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 days
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
Other information
■ each 5 ml contains: sodium 3 mg
■ store between 20-25°C (68-7TF)
■ do not refrigerate
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, butylparaben,
D&C Red # 33, FD&C Blue # 1, flavor,
glycerin, high fructose corn syrup,
microcrystalline cellulose and
carboxymethylcellulose sodium,
propylene glycol, purified water, sodium
benzoate, sorbitol solution, sucralose,
xanthan gum.
Otc - Questions
Questions? Call weekdays from 9:30
AM to 4:30 PM EST at 1-877-798-5944
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 syringe
Grape
Flavor
2 FL OZ (59 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
LOT:
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 GUARANTEED
If 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
* Please review the disclaimer below.