gercare- apap sus extra 206

SPL v7

SPL

SPL Set ID 99ec63ef-aa28-c2fb-e053-2a95a90a9f6d

Route

oral

Published

Effective Date 2021-03-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

acetaminophen (500 mg)

Inactive Ingredients

citric acid monohydrate fd&c red no. 40 methylparaben polyethylene glycol, unspecified sucralose propylene glycol propylparaben water sodium citrate

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

otc monograph drug active Since 2019-06-01

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 500 mg

Medication Information

Warnings

Liver Warning:This product contains acetaminophen. The maximum

daily dose of this product is 6 tablespoonfuls in 24 hours.

Severe liver damage may occur if you take

• more than 8 tablespoonfuls (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 severe skin reactions.

Symptoms may include: • skin reddening • blisters • rash

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

Uses

temporarily relieves minor aches and pains
temporarily reduces fever

Purpose

Pain reliever/Fever reducer

Directions

do not take more than directed

Adults and children 12 years of age and older	Take 1 to 2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours. Do not take for more than 10 days unless directed by a doctor
Children under 12 years	ask a doctor

Other Information

store at room temperature 15°- 30°C (59°-86°F)
protect from freezing
protect from light
TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.

Inactive Ingredients

artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Description

Acetaminophen 500 mg

Principal Display Panel

Section 43683-2

correct typographical errors in dosage section

Section 50565-1

If pregnant or breastfeeding,ask a health professional before use.

Keep out of reach of children.

Section 50568-5

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

When using this product: Do not exceed recommended dose.

Section 50569-3

Ask a doctor before use if you haveliver disease

Do Not Use

with any other drug containing acetaminophen (prescription or non-prescription). 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

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Questions Or Comments?

1-800-540-3765

Stop Use and Ask A Doctor If

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Active Ingredient (in Each 15ml Tablespoonful)

Acetaminophen 500 mg

Structured Label Content

Warnings

Uses

temporarily relieves minor aches and pains
temporarily reduces fever

Purpose

Pain reliever/Fever reducer

Directions

do not take more than directed

Adults and children 12 years of age and older	Take 1 to 2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours. Do not take for more than 10 days unless directed by a doctor
Children under 12 years	ask a doctor

Other Information (Other information)

store at room temperature 15°- 30°C (59°-86°F)
protect from freezing
protect from light
TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.

Inactive Ingredients (Inactive ingredients)

artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 43683-2 (43683-2)

correct typographical errors in dosage section

Section 50565-1 (50565-1)

If pregnant or breastfeeding,ask a health professional before use.

Keep out of reach of children.

Section 50568-5 (50568-5)

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

When using this product: Do not exceed recommended dose.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver disease

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or non-prescription). 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

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Active Ingredient (in Each 15ml Tablespoonful) (Active ingredient (in each 15mL Tablespoonful))

Acetaminophen 500 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains temporarily reduces fever", "43683-2": "correct typographical errors in dosage section", "50565-1": "If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product: Do not exceed recommended dose.", "50569-3": "Ask a doctor before use if you have liver disease", "Purpose": "Pain reliever/Fever reducer", "Warnings": "Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if you take • more than 8 tablespoonfuls (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 severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.", "Directions": "do not take more than directed Adults and children 12 years of age and older Take 1 to 2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours. Do not take for more than 10 days unless directed by a doctor Children under 12 years ask a doctor", "Do not use": "with any other drug containing acetaminophen (prescription or non-prescription). 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", "Overdose warning": "In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.", "Other information": "store at room temperature 15°- 30°C (59°-86°F) protect from freezing protect from light TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.", "Inactive ingredients": "artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose", "Questions or comments?": "1-800-540-3765", "Stop use and ask a doctor if": "new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition.", "Active ingredient (in each 15mL Tablespoonful)": "Acetaminophen 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:01.296391 · Updated: 2026-03-14T23:12:08.624404