Your browser does not support JavaScript! MEJORALITO (ACETAMINOPHEN) LIQUID [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]
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MEJORALITO (acetaminophen) liquid
[GlaxoSmithKline Consumer Healthcare LP]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 finalpart34302/23/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 12/2012
Document Id: f1c1dbed-c70c-446c-8b2b-dd2f2ed32e66
Set id: a2196ba0-35c2-4b71-999b-e1f0a407dee1
Version: 5
Effective Time: 20121203
 
GlaxoSmithKline Consumer Healthcare LP

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