Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Croscarmellose Sodium Gelatin, Unspecified Glycerin Hypromellose, Unspecified Ferrosoferric Oxide Magnesium Stearate Ferric Oxide Yellow Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Sodium Lauryl Sulfate Titanium Dioxide

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2014-02-14

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 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

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

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 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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com ^® 1-800-SHOP CVS

5111609/V-10981

Other Information

•
store at 20 - 25° C (68 - 77° F). Avoid high humidity.
•
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

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.

Principal Display Panel 650 Mg Tablet Bottle Label

CVS

Health_™

Compare to the active ingredient

in Tylenol^® 8HR Arthritis Pain*

Geltabs^†

8HR Arthritis

Pain Relief

DO NOT USE WITH OTHER

MEDICINES CONTAINING

ACETAMINOPHEN

ACETAMINOPHEN

EXTENDED-RELEASE TABLETS, USP 650 mg

Pain reliever; Fever reducer

For the temporary relief

of minor arthritis pain
Lasts up to 8 hours

Use only as directed.

80 GELTABS^†

^†GELATIN-COATED TABLETS

Actual Size

Structured Label Content

Uses (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

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

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)

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com ^® 1-800-SHOP CVS

5111609/V-10981

Other Information (OTHER INFORMATION)

•
store at 20 - 25° C (68 - 77° F). Avoid high humidity.
•
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

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.

Principal Display Panel 650 Mg Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 650 mg Tablet Bottle Label)

CVS

Health_™

Compare to the active ingredient

in Tylenol^® 8HR Arthritis Pain*

Geltabs^†

8HR Arthritis

Pain Relief

DO NOT USE WITH OTHER

MEDICINES CONTAINING

ACETAMINOPHEN

ACETAMINOPHEN

EXTENDED-RELEASE TABLETS, USP 650 mg

Pain reliever; Fever reducer

For the temporary relief

of minor arthritis pain
Lasts up to 8 hours

Use only as directed.

80 GELTABS^†

^†GELATIN-COATED TABLETS

Actual Size

Advanced Ingredient Data

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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", "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 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 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 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2014 CVS/pharmacy CVS.com ® 1-800-SHOP CVS 5111609/V-10981", "OTHER INFORMATION": "• store at 20 - 25° C (68 - 77° F). Avoid high humidity. • 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", "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.", "PRINCIPAL DISPLAY PANEL - 650 mg Tablet Bottle Label": "CVS Health ™ Compare to the active ingredient in Tylenol ® 8HR Arthritis Pain* Geltabs † 8HR Arthritis Pain Relief DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg Pain reliever; Fever reducer For the temporary relief of minor arthritis pain Lasts up to 8 hours Use only as directed. 80 GELTABS † † GELATIN-COATED TABLETS Actual Size"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information