MEJORALITO

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC code: 0135-0448

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- colds
- headache
- flu
- 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

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.

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

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
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 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 take more than directed (see overdose warning)
if needed, repeat dose every 4 hours, while symptoms persist
do not take more than 5 doses in 24 hours, unless directed by a doctor
chew tablets or crush and mix with applesauce or cereal

Age	Weight	Dosage
under 2 yrs	under 24 lbs	ask a doctor
2-3 yrs	24-35 lbs	2 tablets
4-5 yrs	36-47 lbs	3 tablets
6-8 yrs	48-59 lbs	4 tablets
9-10 yrs	60-71 lbs	5 tablets
11 yrs	72-95 lbs	6 tablets

Other information

store below 30°C (86°F)
read and retain carton for complete information

Inactive ingredients

D&C red #27 lake, D&C red #30 lake, flavor, mannitol, sodium saccharin, starch, stearic acid

Questions or comments?

1-800-981-3511 (English/Spanish) weekdays

Principal Display Panel

Mejoralito®

Children's

Acetaminophen

Pain Reliever/Fever Reducer

Fast relief of fever and pain

Cherry Flavor

NO SUGAR ADDED
ASPIRIN & IBUPROFEN FREE

See new warnings information.

32 Chewable Tablets

80 mg in each

Tamper Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Made in Italy

29810XB

MEJORALITO
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0448
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27
ALUMINUM OXIDE
D&C RED NO. 30
MANNITOL
SACCHARIN SODIUM
STARCH, CORN
STEARIC ACID

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	11mm
Flavor	CHERRY	Imprint Code	M
Contains

Packaging
#	Item Code	Package Description
1	NDC:0135-0448-01	1 BOTTLE (BOTTLE) in 1 CARTON
1		32 TABLET, CHEWABLE (TABLET) in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/15/2011	07/31/2013

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2011

Document Id: a2373a92-50a2-4091-bbcf-136362e18a75

Set id: 3fb402e4-d6fb-4231-b3a6-fe8af8f00881

Version: 3

Effective Time: 20110920

GlaxoSmithKline Consumer Healthcare LP

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer