Drug Facts

MEJORALITO- acetaminophen liquid 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active ingredient (in each 1/2 teaspoon)

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 dosage every 4 hours
do not take more than 5 doses in 24 hours, unless directed by a doctor
use enclosed pre-marked measuring cup for accuracy*
may be administered alone or mixed with formula, milk, juice or cereal

Age

Weight

Dosage

under 2 yrs

under 24 lbs

ask a doctor

2-3 yrs

24-35 lbs

1 teaspoon

4-5 yrs

36-47 lbs

1 1/2 teaspoons

6-8 yrs

48-59 lbs

2 teaspoons

9-10 yrs

60-71 lbs

2 1/2 teaspoons

11 yrs

72-95 lbs

3 teaspoons

*TSP = teaspoon on measuring cup

Other information

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

Inactive ingredients

benzoic acid, FD&C red #40, flavor, glycerin, *hydrochloric acid, polyethylene glycol, potassium sorbate, propylene glycol, purified water, sodium saccharin, *sodium hydroxide, sorbitol solution

*contains one or more of these ingredients

Questions or comments?

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

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

Made in China

©2010, GlaxoSmithKline

Principal Display Panel

NDC 0135-0470-01

Mejoralito®

Children's

Acetaminophen

Pain Reliever/Fever Reducer

Fast relief of fever and pain

NO SUGAR ADDED

ASPIRIN & IBUPROFEN FREE

See new warnings information.

Raspberry Flavor

2 fl oz Liquid

80 mg in each 1/2 teaspoon

29811XC

Mejoralito Carton
MEJORALITO 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0470
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HYDROCHLORIC ACID 
POLYETHYLENE GLYCOLS 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
SORBITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0470-011 in 1 CARTON
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/23/201107/01/2013
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 10/2013
 
GlaxoSmithKline Consumer Healthcare LP