Childrens Pain Relief Oral Suspension

Manufacturer
Pharmacy Value Alliance, LLC | AptaPharma Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:16:22

Label at a glance#

ProductChildrens Pain Relief Oral Suspension
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL =1 teaspoonful)
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 a skin 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 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.

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 aserious 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
Taking more than the recommended dose (overdose)
may cause liver damage. 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; tsp = teaspoonful
■ 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 unless directed
by a doctor.

Weight (Ib)       Age (yr)       Dose (mL or tsp)*
under 24          under 2 years      ask a doctor
24-35                2-3 years          5 mL (1 tsp)
36-47                4-5 years       7.5 mL (1½ tsp)
48-59                6-8 years         10 mL (2 tsp)
60-71                9-10 year       12.5 mL (2½ tsp)
72-95                   11 year          15 mL (3 tsp)

*or as directed by a doctor
Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.

OTHER SAFETY INFORMATION

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®

Children's Pain Relief

PAIN RELIEVER· FEVER REDUCER
ACETAMINOPHEN

ORAL SUSPENSION
Grape Flavor

Premier
Value®

Compare to the active
ingredients in Children's
TYLENOL® Oral Suspension**

Ages 2 - 11 years

Children's Pain Relief

PAIN REDUCER - FEVER REDUCER
ACETAMINOPHEN

ORAL SUSPENSION

160 mg per 5 mL

• Alcohol Free
• Aspirin Free
• Ibuprofen Free

Use ONLY enclosed
dosage cup

Grape Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSING

If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.

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 Children's
Tylenol® Oral Suspension.

BX-073

15
711198
10/17

PRODUCT LABEL

241-04 Grape Outer241-04 Grape Outer

241-04 Grape Inner241-04 Grape Inner

                                                  Premier Value Children's Pain Relief Oral Suspension Grape Flavor

end res

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-24168016-241-04

Ingredients#

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

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

Source Document#

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openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
591225e9-7e54-4ff2-94d7-4b45ffb7eb8041768152-16dc-4ce8-bf46-39fec2d24aa02024-12-29WarningsExact identifier
spl set id: 41768152-16dc-4ce8-bf46-39fec2d24aa0

Reported adverse events (FAERS/openFDA)#

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