Hst 265 (268)

SPL v6

SPL

SPL Set ID f6dc5576-9ba3-436c-87f5-8d0d6258adef

Route

ORAL

Published

Effective Date 2024-10-23

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 Microcrystalline Cellulose 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 2019-07-01

Description

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

How Supplied

Acetaminophen ER 650 mg Tablets NDC: 71335-1340-7: 20 Tablets in a BOTTLE NDC: 71335-1340-1: 30 Tablets in a BOTTLE NDC: 71335-1340-2: 100 Tablets in a BOTTLE NDC: 71335-1340-3: 50 Tablets in a BOTTLE NDC: 71335-1340-4: 60 Tablets in a BOTTLE NDC: 71335-1340-6: 19 Tablets in a BOTTLE NDC: 71335-1340-5: 120 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Pain reliever/fever reducer

How Supplied

Acetaminophen ER 650 mg Tablets

NDC: 71335-1340-7: 20 Tablets in a BOTTLE
NDC: 71335-1340-1: 30 Tablets in a BOTTLE
NDC: 71335-1340-2: 100 Tablets in a BOTTLE
NDC: 71335-1340-3: 50 Tablets in a BOTTLE
NDC: 71335-1340-4: 60 Tablets in a BOTTLE
NDC: 71335-1340-6: 19 Tablets in a BOTTLE
NDC: 71335-1340-5: 120 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Acetaminophen 650 mg

Uses

• temporarily relieves minor aches and pains due to:

• minor pain of arthritis

• muscular aches

• backache

• premenstrual and menstrual cramps

• the common cold

• headache

• toothache

• temporarily reduces fever

Section 51945-4

Acetaminophen ER 650 mg Tablets

Warnings

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 everyday 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 (see overdose warning)

Adults: • 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

• do not use for more than 10 days unless directed by a doctor

Under 18 years of age: ask a doctor

Do Not Use

• with any other drugs 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.

Other Information

• store between 20-25°C (68-77°F)

Inactive Ingredients

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

Questions Or Comments ?

1-800-540-3765

Stop Use and Ask 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.

If Pregnant Or Breast Feeding

ask a health professional before use.

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

Active Ingredient (in Each Caplet)

Acetaminophen 650 mg

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use if You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses (USES)

Section 51945-4 (51945-4)

Acetaminophen ER 650 mg Tablets

Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

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 (DIRECTIONS)

• do not take more than directed (see overdose warning)

Do Not Use (Do not use)

How Supplied (HOW SUPPLIED)

Acetaminophen ER 650 mg Tablets

NDC: 71335-1340-7: 20 Tablets in a BOTTLE
NDC: 71335-1340-1: 30 Tablets in a BOTTLE
NDC: 71335-1340-2: 100 Tablets in a BOTTLE
NDC: 71335-1340-3: 50 Tablets in a BOTTLE
NDC: 71335-1340-4: 60 Tablets in a BOTTLE
NDC: 71335-1340-6: 19 Tablets in a BOTTLE
NDC: 71335-1340-5: 120 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (OTHER INFORMATION)

• store between 20-25°C (68-77°F)

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 ?)

1-800-540-3765

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

If Pregnant 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)

Active Ingredient (in Each Caplet) (ACTIVE INGREDIENT (IN EACH CAPLET))

Acetaminophen 650 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

Ask A Doctor Or Pharmacist Before Use if You Are (Ask a doctor or pharmacist before use if you are )

taking the blood thinning drug warfarin.

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": "MICROCRYSTALLINE CELLULOSE", "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: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever", "51945-4": "Acetaminophen ER 650 mg Tablets", "PURPOSE": "Pain reliever/fever reducer", "WARNINGS": "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 everyday 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 (see overdose warning) Adults: • 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 • do not use for more than 10 days unless directed by a doctor Under 18 years of age: ask a doctor", "Do not use": "• with any other drugs 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.", "HOW SUPPLIED": "Acetaminophen ER 650 mg Tablets NDC: 71335-1340-7: 20 Tablets in a BOTTLE NDC: 71335-1340-1: 30 Tablets in a BOTTLE NDC: 71335-1340-2: 100 Tablets in a BOTTLE NDC: 71335-1340-3: 50 Tablets in a BOTTLE NDC: 71335-1340-4: 60 Tablets in a BOTTLE NDC: 71335-1340-6: 19 Tablets in a BOTTLE NDC: 71335-1340-5: 120 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "OTHER INFORMATION": "• store between 20-25°C (68-77°F)", "INACTIVE INGREDIENTS": "hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid", "QUESTIONS OR COMMENTS ?": "1-800-540-3765", "Stop use and ask 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.", "If pregnant or breast-feeding": "ask a health professional before use.", "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 for children even if you do not notice any signs or symptoms", "ACTIVE INGREDIENT (IN EACH CAPLET)": "Acetaminophen 650 mg", "Ask a doctor before use if you have": "liver disease.", "Ask a doctor or pharmacist before use if you are ": "taking the blood thinning drug warfarin."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:00.184938 · Updated: 2026-03-14T23:04:23.419434