CHILDRENS PAIN AND FEVER, GRAPE FLAVOR- acetaminophen suspension

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient
(in each 5 mL = 1 teaspoonful)
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 nyour 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 ever, 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 other 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 ■ 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 the right dose on the 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 (lb)	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 1/2 tsp)
48-59	6 - 8 years	10 mL (2 tsp)
60-71	9 - 10 years	12.5. mL (2 1/2 tsp)
72-95	11 years	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 20-25ºC (68-77ºF)
■ do not refrigerate
■ Keep carton for full directions for use.
INACTIVE INGREDIENT

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
QUESTIONS

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

Walgreens

Compare to Children's Tylenol®
Oral Suspension active ingredient††

NDC: 0363-0323-24

children's

Pain & Fever

ACETAMINOPHEN
160 mg PER 5 mL

PAIN RELIEVER /
FEVER REDUCER
ORAL SUSPENSION

ALCOHOL FREE
ASPIRIN FREE
IBUPROFEN FREE

AGES
2-11
YEARS

GRAPE FLAVOR

4 FL OZ (118 mL)

This product is bot manufactured or distributed by Johnson
& Johnson Consumer Inc., |McNeil Consumer Healthcare,
distributor of Children's Tylenol® Oral Suspension.

ITEM 268955 W000OO-0

REV-1020

DO NOT USE IF PRINTED NECKBAND IS
BROKEN OR MISSING

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey

DISTRIBUTED BY WALGREEN CO.
200 WILMONT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2020 Walgreen Co.

DOSAGE
CUP PROVIDED
BX-114

ORG1020-F

Carton

Bottle

res

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER, GRAPE FLAVOR
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0323
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 0363-0323-24	1 in 1 CARTON	11/05/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	11/05/2020

Labeler - Walgreen Company (008965063)

Registrant - AptaPharma Inc. (790523323)

Name	Address	ID/FEI	Business Operations
Establishment
AptaPharma Inc.		790523323	manufacture(0363-0323)

CHILDRENS PAIN AND FEVER, GRAPE FLAVOR- acetaminophen suspension

Childrens Pain and Fever, Grape flavor by

Drug Labeling and Warnings

Drug Details [pdf]