GESTEIRA- acetaminophen liquid

Gesteira by

Drug Labeling and Warnings

Gesteira by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tbsp. 15 mL)

Acetaminophen 675 mg

PURPOSE

Purpose

Pain Reliever/ Fever Reducer

INDICATIONS & USAGE

Uses

• For the temporary relief of minor aches and pains associated with headache, muscular ache, backache, minor arthritis pain, the common cold, toothache, menstrual crams and for the reduction of fever.

WARNINGS

Warnings

• Do not exceed recommended dosage

Taking more than the recommendeddose (overdose) may not provide more relief and could cause serious health problems.

DO NOT USE

Do not use

• with an other product containing acetaminophen
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or get worse
• redness or swelling is present

WARNINGS AND PRECAUTIONS

Alcohol Warning: If you consume 3 or more alcoholic drinks everyday, ask your doctor whether you should take acetaminophen or other pain relievers/ fever reducers. Acetaminophen may cause liver damage. Acetaminophen should not be taken with moderate amounts of alcohol.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 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.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years and over: One tablespoonful every 4-6 hours as needed; do not take more than 4 tablespoonsfuls in 24 hours. Children under 12 years of age: Consult a doctor. Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose (overdose) of Acetaminophen and could cause serious health problems.

OTHER SAFETY INFORMATION

Other information

Store at controlled room temperature: 15°-30°C (59°-86°F). Tamper-Evident Feature: Do not use if cello-band over cap is torn, broken or missing.

INACTIVE INGREDIENT

Inactive ingredients citric acid, ethyl alcohol, FD&C yellow # 6, flavor, glycerin, methylparaben, propolyne glycol, propylparaben, purified water.

QUESTIONS

Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GESTEIRA 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-052
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	675 mg  in 675 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-052-04	1 in 1 CARTON
1		120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)