PREMIER VALUE CHILDRENS ACETAMINOPHEN MELTS- acetaminophen tablet, chewable

Premier Value Childrens Acetaminophen Melts by

Drug Labeling and Warnings

Premier Value Childrens Acetaminophen Melts 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 80 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • flu
  • sore throat
  • toothache
• 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

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

• 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.

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 for adults as well as for children 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. If possible, use weight to dose; otherwise, use age.
• Chew before swallowing; this product will soften in mouth for ease of chewing
• 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 (tablets)*
Under 24	Under 2 years	ask a doctor
24-35	2-3 years	2 tablets
36-47	4-5 years	3 tablets
48-59	6-8 years	4 tablets
60-71	9-10 years years	5 tablets
72-95	11	6 tablets

Other information

• store at controlled room temperature 20-25ºC (68-77ºF). Avoid high humidity. Protect from light
• see end flap for expiration date and lot number

Inactive ingredients

citric acid, corn starch, crospovidone, D&C red 30 aluminum lake, dextrose, ethylcellulose, FD&C blue 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose

Questions or comments?

1-866-467-2748

Product Packaging

NDC: 68016-196-00

Compare to Children's Tylenol® Meltaways® Active Ingredient*

Premier Value

Children's
Pain Reliever

Ages 2-6

ACETAMINOPHEN

pain reliever/fever reducer
Aspirin Free/ Ibuprofen Free

GRAPE FLAVOR

30 count – 80mg each

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

INGREDIENTS AND APPEARANCE

PREMIER VALUE CHILDRENS ACETAMINOPHEN MELTS 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-196
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 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)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	13mm
Flavor	GRAPE	Imprint Code	RP080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-196-00	1 in 1 CARTON
1		30 in 1 BOTTLE, PLASTIC; 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	12/06/2004

Labeler - Chain Drug Consortium (101668460)