Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Croscarmellose Sodium Gelatin Glycerin Hypromelloses Ferrosoferric Oxide Ferric Oxide Yellow Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Starch, Corn Sodium Lauryl Sulfate Titanium Dioxide Povidones

Identifiers & Packaging

Pill Appearance

Imprint: 350 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

ANDA Active Since 2012-12-21

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 650 mg

Uses

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

Warnings

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

•
more than 6 geltabs 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

Directions

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

adults	▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time. ▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass). ▪ swallow whole - do not crush, chew, split or dissolve ▪ do not take more than 6 geltabs 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•
if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
•
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Questions?

Call 1-800-406-7984

Other Information

•
store at 20 - 25° C (68 - 77° F). Avoid high humidity.
•
see end panel for batch number and expiration date
•
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients

Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

Principal Display Panel

Premier Value ^®

NDC 68016-340-08

Use only as directed.

See New Warnings Information

EASY TO OPEN BOTTLE

Lasts up to 8 hours

Arthritis Pain Relief

Acetaminophen Extended-Release Tablets, USP 650 mg

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

80 GELTABS ^* 650 mg EACH

( ^* Gelatin-Coated Tablets)

COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL ^® ARTHRITIS PAIN ^†

DISTRIBUTED BY CHAIN DRUG CONSORTIUM

5095711/0512

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
•
the tablet got stuck in your throat

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 Geltab)

Acetaminophen USP, 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)

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

Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

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

•
more than 6 geltabs 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

Directions (DIRECTIONS)

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

adults	▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time. ▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass). ▪ swallow whole - do not crush, chew, split or dissolve ▪ do not take more than 6 geltabs 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 (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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
•
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Questions? (QUESTIONS?)

Call 1-800-406-7984

Other Information (OTHER INFORMATION)

•
store at 20 - 25° C (68 - 77° F). Avoid high humidity.
•
see end panel for batch number and expiration date
•
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients (INACTIVE INGREDIENTS)

Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Premier Value ^®

NDC 68016-340-08

Use only as directed.

See New Warnings Information

EASY TO OPEN BOTTLE

Lasts up to 8 hours

Arthritis Pain Relief

Acetaminophen Extended-Release Tablets, USP 650 mg

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

80 GELTABS ^* 650 mg EACH

( ^* Gelatin-Coated Tablets)

COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL ^® ARTHRITIS PAIN ^†

DISTRIBUTED BY CHAIN DRUG CONSORTIUM

5095711/0512

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
•
the tablet got stuck in your throat

These could be signs of a serious condition.

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.)

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 Geltab) (ACTIVE INGREDIENT (IN EACH GELTAB))

Acetaminophen USP, 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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "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 GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONES", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "• temporarily relieves minor aches and pains due to: • muscular aches • backache • headache • toothache • the common cold • minor pain of arthritis • premenstrual and menstrual cramps • 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 geltabs 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", "DIRECTIONS": "• do not take more than directed (see overdose warning) adults ▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time. ▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass). ▪ swallow whole - do not crush, chew, split or dissolve ▪ do not take more than 6 geltabs 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. • if you are allergic to acetaminophen or any of the inactive ingredients in this product.", "QUESTIONS?": "Call 1-800-406-7984", "OTHER INFORMATION": "• store at 20 - 25° C (68 - 77° F). Avoid high humidity. • see end panel for batch number and expiration date • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.", "INACTIVE INGREDIENTS": "Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "Premier Value ® NDC 68016-340-08 Use only as directed. See New Warnings Information EASY TO OPEN BOTTLE Lasts up to 8 hours Arthritis Pain Relief Acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 80 GELTABS * 650 mg EACH ( * Gelatin-Coated Tablets) COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL ® ARTHRITIS PAIN † DISTRIBUTED BY CHAIN DRUG CONSORTIUM 5095711/0512", "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 • the tablet got stuck in your throat 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 GELTAB)": "Acetaminophen USP, 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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information