Gesteira

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (675 mg)

Inactive Ingredients

D&c Red No. 33 Anhydrous Citric Acid Alcohol Fd&c Red No. 40 Glycerin Methylparaben Propylene Glycol Propylparaben Sodium Citrate Saccharin Sodium Sucralose Sucrose Water

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-02-21

Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause sever skin reaction. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor if you have liver disease

Ask a doctor or a pharmacist before use if you are taking the blood thinning drug warfarin

Stope use and ask a doctor if

pain get worse or lasts more than 10 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

Indications and Usage

Uses

For the temporary relief of minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever.

Dosage and Administration

Directions

do not take more than directed (see overdose warning)

Age	Dose
adults and children 12 years and over	take 1 tablespoonful (15 mL) every 6 hours as needed do not take more than 4 tablespoonfuls in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Description

Active ingredient (in each tbsp. 15 mL) Acetaminophen 675 mg

Section 50565-1

Keep out of reach of children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222 Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive ingredientscitric acid, ethyl alcohol (0.16%), FD&C red #40, flavor, glycerin, methylparaben, propolyne glycol, propylparaben, sodium citrate, sodium saccharin, sucralose, sucrose, water

Section 51945-4

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Pain Reliever/ Fever Reducer

Section 55106-9

Active ingredient (in each tbsp. 15 mL)

Acetaminophen 675 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever.

Dosage and Administration (34068-7)

Directions

do not take more than directed (see overdose warning)

Age	Dose
adults and children 12 years and over	take 1 tablespoonful (15 mL) every 6 hours as needed do not take more than 4 tablespoonfuls in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause sever skin reaction. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor if you have liver disease

Ask a doctor or a pharmacist before use if you are taking the blood thinning drug warfarin

Stope use and ask a doctor if

pain get worse or lasts more than 10 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

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222 Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive ingredientscitric acid, ethyl alcohol (0.16%), FD&C red #40, flavor, glycerin, methylparaben, propolyne glycol, propylparaben, sodium citrate, sodium saccharin, sucralose, sucrose, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain Reliever/ Fever Reducer

Section 55106-9 (55106-9)

Active ingredient (in each tbsp. 15 mL)

Acetaminophen 675 mg

Advanced Ingredient Data

[{"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "675", "strengthDenominator": "15", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For the temporary relief of minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever.", "34068-7": "Directions do not take more than directed (see overdose warning) Age Dose adults and children 12 years and over take 1 tablespoonful (15 mL) every 6 hours as needed do not take more than 4 tablespoonfuls in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor ", "34071-1": "Warnings Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause sever skin reaction. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor if you have liver disease Ask a doctor or a pharmacist before use if you are taking the blood thinning drug warfarin Stope use and ask a doctor if pain get worse or lasts more than 10 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", "50565-1": "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222 Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.", "51727-6": "Inactive ingredients citric acid, ethyl alcohol (0.16%), FD&C red #40, flavor, glycerin, methylparaben, propolyne glycol, propylparaben, sodium citrate, sodium saccharin, sucralose, sucrose, water", "53413-1": "Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Pain Reliever/ Fever Reducer", "55106-9": "Active ingredient (in each tbsp. 15 mL) Acetaminophen 675 mg"}