SPL v2
SPL
SPL Set ID 113df1bc-a217-33ea-e063-6294a90a4643
Route
ORAL
Published
Effective Date 2024-05-14
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Silicon Dioxide Hydroxyethyl Cellulose (140 Mpa.s At 5%) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone, Unspecified Starch, Corn Sodium Starch Glycolate Type B Potato Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: I;06 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-15

Description

Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg

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
Warnings

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

  • more than 6 tablets 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

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 and children 12 years and over

    • take 2 tablets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 tablets in 24 hours
    • 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.

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

Drug Facts

Active ingredient (in each extended-release tablet)



Acetaminophen USP 650 mg

Other Information
  • store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
  • do not use if carton is opened or foil inner seal is broken
  • Meets USP dissolution test 3
Inactive Ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin



Questions or comments? 

 call 1-855-274-4122



DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N., SEATTLE, WA 98109

©2024 AMAZON.COM, INC. OR ITS

AFFILIATES. ALL RIGHTS RESERVED.



Made in India

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.



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.

Package Label Principal Display Panel 650 Mg (24 Tablets Bottle)

amazon

basic+care

8 Hour            NDC 72288-698-10

Pain Relief

1. push down

2. Turn cap

Acetaminophen

Extended-Release Tablets USP,

650 mg

Pain Reliever/Fever Reducer

For up to 8 Hours Relief of

Minor Muscle Aches and Pain

100 CAPLETS*

*CAPSULE-SHAPED TABLETS

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN



Package Label Principal Display Panel 650 Mg (24 Tablets Container Carton)

amazon

basic+care

8 Hour Muscle          NDC 72288-698-10

Aches & Pain

Compare to

Tylenol® 8HR

Caplets

active ingredient**

Acetaminophen

Extended-Release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

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

100 CAPLETS*

*CAPSULE-SHAPED TABLETS




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
Purpose

Pain reliever/fever reducer

Warnings

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

  • more than 6 tablets 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

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 and children 12 years and over

    • take 2 tablets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 tablets in 24 hours
    • 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.

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

Drug Facts

Active ingredient (in each extended-release tablet)



Acetaminophen USP 650 mg

Other Information (Other information)
  • store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
  • do not use if carton is opened or foil inner seal is broken
  • Meets USP dissolution test 3
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin



Questions or comments? 

 call 1-855-274-4122



DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N., SEATTLE, WA 98109

©2024 AMAZON.COM, INC. OR ITS

AFFILIATES. ALL RIGHTS RESERVED.



Made in India

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.



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

Keep Out of Reach of Children. (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.

Package Label Principal Display Panel 650 Mg (24 Tablets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Bottle))

amazon

basic+care

8 Hour            NDC 72288-698-10

Pain Relief

1. push down

2. Turn cap

Acetaminophen

Extended-Release Tablets USP,

650 mg

Pain Reliever/Fever Reducer

For up to 8 Hours Relief of

Minor Muscle Aches and Pain

100 CAPLETS*

*CAPSULE-SHAPED TABLETS

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN



Package Label Principal Display Panel 650 Mg (24 Tablets Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton))

amazon

basic+care

8 Hour Muscle          NDC 72288-698-10

Aches & Pain

Compare to

Tylenol® 8HR

Caplets

active ingredient**

Acetaminophen

Extended-Release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

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

100 CAPLETS*

*CAPSULE-SHAPED TABLETS




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