JUNIOR ACETAMINOPHEN AGES 6-11- acetaminophen tablet, orally disintegrating

Junior Acetaminophen by

Drug Labeling and Warnings

Junior Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• ▪ temporarily relieves minor aches and pains due to:
  • ▪ the common cold
  • ▪ flu
  • ▪ headache
• ▪ temporarily reduces fever

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

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 a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage (see overdose warning).

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.

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 at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• ▪ this product does not contain directions or complete warnings for adult use
• ▪ do not give more than directed (see overdose warning)
• ▪ find the right dose on chart below. If possible, use weight to dose; otherwise use age.
• ▪ if needed, repeat dose every 4 hours while symptoms last
• ▪ dissolve in mouth or chew before swallowing
• ▪ 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)	Tablets
under 48	under 6 years	Ask a doctor
48-59	6-8 years	2
60-71	9-10 years	2 1/2
72-95	11 years	3
96 and over	12 years	4

Other information

• ▪ store at between 20ºC-25ºC (68ºF-77ºF). Avoid high humidity
• ▪ see end flap for expiration date and lot number

Inactive ingredients

citric acid, corn starch, crospovidone, D&C red no. 30 aluminum lake, dextrose, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose

Principal Display Panel

Compare to Jr. Strength Tylenol® Meltaways® Active Ingredient*

Premier Value

Junior

Pain Reliever

Ages 6-11
ACETAMINOPHEN
Pain Reliever/Fever Reducer

Aspirin-Free

Ibuprofen-Free

SEE NEW WARNINGS INFORMATION

Grape Flavor

24 COUNT - 160 mg each

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd.,

Suite 101, Boca Raton FL 33431

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.

INGREDIENTS AND APPEARANCE

JUNIOR ACETAMINOPHEN  AGES 6-11
acetaminophen tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-198
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	GRAPE	Imprint Code	RP160
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-198-00	4 in 1 CARTON	08/07/2015
1		6 in 1 BLISTER PACK; 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	08/07/2015

Labeler - Chain Drug Consortium (101668460)