Infants Pain Relief Oral Suspension Grape Flavor

Manufacturer
Pharmacy Value Alliance, LLC
Effective date
2018-10-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:05

Label at a glance#

ProductInfants Pain Relief Oral Suspension Grape Flavor
Active ingredientACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)    Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose    Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses temporarily:

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

WARNINGS SECTION

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 SECTION

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 SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking
the blood thinning drug warfarin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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 SECTION

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 SECTION

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 SECTION

Questions? Call weekdays from 9:30
AM to 4:30 PM EST at 1-877-798-5944

Principal Display Panel

PACKAGE LABEL.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

242-02 Outer242-02 Outer

Product Label - Inner

242-02 Inner242-02 Inner

                                             Premier Value® Infants' Pain Relief

end res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN2
307668acetaminophen 32 MG/ML Oral SuspensionSCD2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY2
307668APAP 32 MG/ML Oral SuspensionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-242-022020-01-31C16284748780-19d75b9cf-e11a-f424-e053-dadaa90a57ceInfants' Pain Relief Oral Suspension Grape Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-242-02Infants Pain Relief Oral Suspension Grape Flavor1 in 1 CARTONSUSPENSION12
68016-242-02Infants Pain Relief Oral Suspension Grape Flavor59 mL in 1 BOTTLESUSPENSION592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-242INFANTS PAIN RELIEF ORAL SUSPENSION GRAPE FLAVOR (ACETAMINOPHEN) SUSPENSION [PHARMACY VALUE ALLIANCE, LLC]2Legacy NDC, 2 package rows20181025_ce5bf0fe-7e75-4528-8d0d-2d11b813252d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-24268016-242-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
56351ed9-903e-4d1a-bb4e-53e9ce0c38aace5bf0fe-7e75-4528-8d0d-2d11b813252d2018-10-24WarningsExact identifier
spl id: 56351ed9-903e-4d1a-bb4e-53e9ce0c38aa
spl set id: ce5bf0fe-7e75-4528-8d0d-2d11b813252d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.