Childrens Pain Relief Oral Suspension

Manufacturer
Pharmacy Value Alliance, LLC | AptaPharma Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:16:28

Label at a glance#

ProductChildrens Pain Relief Oral Suspension
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 =1 teaspoonful)
Acetaminophen   160 mg

OTC - PURPOSE SECTION

Purpose
Acetaminophen.... 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,

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 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
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 adoctor.

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 (1 Y2 tsp)
48-59             6-8 years          10 mL (2 tsp)
60-71             9-10 year          12.5 mL (2Y2 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

Other information
■ each 5 mL (1 tsp) contains: sodium 3 mg
■ store between 20-25°C (68-77oF)
■ do not refrigerate
■ Keep carton for full directions for use.

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid,
butylparaben, FD&C red #40, 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

Cherry Flavor

Premier
Value®

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

Ages 2-11 years

Children's
Pain Relief

PAIN RELIEVER – FEVER REDUCER
ACETAMINOPHEN

ORAL SUSPENSION
160 mg per 5 mL

• Alcohol Free
• Aspirin Free
• Ibuprofen Free

Use ONLY enclosed
dosage cup

Cherry Flavor
4 FL OX (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 Tyleno!® Oral Suspension.

BX-072

711198

10/17

Product Label

240-04 Outer240-04 Outer

240-04 Inner240-04 Inner

                      Premier Value® Children's Pain Relief ACETAMINOPHEN ORAL SUSPENSION Cherry Flavor

240-04 Outer240-04 Outer

240-04 Inner240-04 Inner

end res

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-24068016-240-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
f58f7bd7-3889-45d0-9e7e-aea670b64dd78fbc5986-28f3-40c1-9f86-6001ae8af9c52024-12-29WarningsExact identifier
spl set id: 8fbc5986-28f3-40c1-9f86-6001ae8af9c5

Reported adverse events (FAERS/openFDA)#

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