Infants Pain Relief Oral Suspension Grape Flavor
FDA Label NDC 68016-242

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Infants Pain Relief Oral Suspension Grape Flavor (NDC 68016-242). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Dosing 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

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.