CHILDRENS PAIN RELIEF ORAL SUSPENSION- acetaminophen suspension

Childrens Pain Relief Oral Suspension by

Drug Labeling and Warnings

Childrens Pain Relief Oral Suspension by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance, LLC, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 5 mL =1 teaspoonful)
Acetaminophen   160 mg

PURPOSE

Purpose
Acetaminophen.... 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 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,

DO NOT USE

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.

ASK DOCTOR

Ask a doctor before use if your child has liver disease

ASK DOCTOR/PHARMACIST

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

WHEN USING

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

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
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

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

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

QUESTIONS

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

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

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

end res

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEF ORAL SUSPENSION 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-240
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-240-04	1 in 1 CARTON	10/01/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/01/2018

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-240)