1201a-fst-2023-0609

SPL v2

SPL

SPL Set ID c003a34a-bfe5-4298-8a4e-8c75576f5674

Route

ORAL

Published

Effective Date 2023-06-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Hydroxyethyl Cellulose (140 Mpa.s At 5%) Hypromellose 2910 (6 Mpa.s) Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Povidone K30 Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: G650 Shape: capsule Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2023-06-09

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

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

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets 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	do not use

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

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.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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 for children even if you do not notice any signs or symptoms.

Other Information

store between 20-25°C (68-77°F)
retain carton for complete product information and warnings

Inactive Ingredients

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9 am to 7 pm EST

Principal Display Panel

NDC 70677-1123-1

COMPARE TO TYLENOL® 8HR ACTIVE INGREDIENT

Foster & Thrive™

8 Hour Pain Relief

Acetaminophen

Extended-Release Tablets, 650 mg

PAIN RELIEVER/FEVER REDUCER

For up to 8 Hour Relief of Minor Muscle Aches and Pain

ACTUAL SIZE

100 CAPLETS** - 650 MG EACH

**CAPSULE-SHAPED BI-LAYER TABLETS

Stop Use and Ask A Doctor If

pain gets 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.

Active Ingredient (in Each Caplet)

Acetaminophen 650 mg

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets 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	do not use

Do Not Use (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

Allergy Alert (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.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Overdose Warning (Overdose warning)

Other Information (Other information)

store between 20-25°C (68-77°F)
retain carton for complete product information and warnings

Inactive Ingredients (Inactive ingredients)

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

Call 833-358-6431 Monday to Friday 9 am to 7 pm EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 70677-1123-1

COMPARE TO TYLENOL® 8HR ACTIVE INGREDIENT

Foster & Thrive™

8 Hour Pain Relief

Acetaminophen

Extended-Release Tablets, 650 mg

PAIN RELIEVER/FEVER REDUCER

For up to 8 Hour Relief of Minor Muscle Aches and Pain

ACTUAL SIZE

100 CAPLETS** - 650 MG EACH

**CAPSULE-SHAPED BI-LAYER TABLETS

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

pain gets 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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 650 mg

Advanced Ingredient Data

[{"name": "HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)", "unii": "8136Y38GY5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if you have liver disease", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Pain reliever/fever reducer", "Directions": "do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets 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 do not use", "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", "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.", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product", "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 for children even if you do not notice any signs or symptoms.", "Other information": "store between 20-25°C (68-77°F) retain carton for complete product information and warnings", "Inactive ingredients": "hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid", "Questions or comments?": "Call 833-358-6431 Monday to Friday 9 am to 7 pm EST", "PRINCIPAL DISPLAY PANEL": "NDC 70677-1123-1 COMPARE TO TYLENOL® 8HR ACTIVE INGREDIENT Foster & Thrive™ 8 Hour Pain Relief Acetaminophen Extended-Release Tablets, 650 mg PAIN RELIEVER/FEVER REDUCER For up to 8 Hour Relief of Minor Muscle Aches and Pain ACTUAL SIZE 100 CAPLETS** - 650 MG EACH **CAPSULE-SHAPED BI-LAYER TABLETS", "Stop use and ask a doctor if": "pain gets 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.", "Active ingredient (in each caplet)": "Acetaminophen 650 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:53.544708 · Updated: 2026-03-14T23:01:12.726296