699r Dollar General 55910-892 Acetaminophen Extended Release Tablets 650 Mg Arthritis Pain

699r Dollar General 55910-892 Acetaminophen Extended Release Tablets 650 Mg Arthritis Pain
SPL v2
SPL
SPL Set ID ea2eae7c-e9bd-534c-e053-2a95a90a26c8
Route
ORAL
Published
Effective Date 2023-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Hypromellose, Unspecified Sodium Starch Glycolate Type A Starch, Corn Povidone K30 Magnesium Stearate Hydroxyethyl Cellulose (140 Mpa.s At 5%) Microcrystalline Cellulose Triacetin Carnauba Wax Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 71 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2023-04-29

Description

Active ingredient (in each caplet) Acetaminophen 650 mg


Medication Information

Indications and Usage

Uses

• temporarily relieves minor aches and pains due to:

o minor pain of arthritis

o muscular aches

o backache

o premenstrual and menstrual cramps

o the common cold

o headache

o toothache

• temporarily reduces fever



Dosage and Administration

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



Description

Active ingredient (in each caplet) Acetaminophen 650 mg

Section 44425-7

Other information

• store between 20-25ºC (68-77ºF)

• The FDA approved Dissolution methods differ from USP



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

Section 50566-9

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



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 50570-1

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

Section 51727-6

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

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 caplet)

Acetaminophen 650 mg

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 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.


Structured Label Content

Indications and Usage (34067-9)

Uses

• temporarily relieves minor aches and pains due to:

o minor pain of arthritis

o muscular aches

o backache

o premenstrual and menstrual cramps

o the common cold

o headache

o toothache

• temporarily reduces fever



Dosage and Administration (34068-7)

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



Section 44425-7 (44425-7)

Other information

• store between 20-25ºC (68-77ºF)

• The FDA approved Dissolution methods differ from USP



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

Section 50566-9 (50566-9)

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



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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

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 caplet)

Acetaminophen 650 mg

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 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.


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