INFANTS PAIN RELIEF ORAL SUSPENSION CHERRY FLAVOR- acetaminophen suspension

Infants Pain Relief Oral Suspension Cherry Flavor by

Drug Labeling and Warnings

Infants Pain Relief Oral Suspension Cherry Flavor 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)       Acetaminophen 160 mg

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 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.

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
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
   unless directed by a doctor.

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 (68-77oF)
■ do not refrigerate

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®

Infants'

Pain Relief

PAIN RELIEVER - FEVER REDUCER

ACETAMINOPHEN

ORAL SUSPENSION

Cherry 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

Cherry

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-076

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 PAIN RELIEVER - FEVER REDUCER ACETAMINOPHEN ORAL SUSPENSION Cherry Flavor

end res

INGREDIENTS AND APPEARANCE

INFANTS PAIN RELIEF ORAL SUSPENSION CHERRY FLAVOR 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-243
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-243-02	1 in 1 CARTON	10/01/2018
1		59 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(68016-243)