ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • backache
  • muscular aches
  • 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 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks ever 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 a medical help right away.

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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Other information

• store between 20-25°C (68-77°F)

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hydroxyethyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose povidone, pregelatinized starch, sodium lauryl sulfate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient of Tylenol® 8HR Arthritis Pain†

8 HR ARTHRITIS PAIN RELIEF

ACETAMINOPHEN

EXTENDED-RELEASE TABLETS 650 mg

PAIN RELIEVER/FEVER REDUCER

for the temporary relief of minor arthritis pain

CAPLETS

*CAPSULE-SHAPED BI-LAYER TABLETS

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Arthritis Pain.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Product Label

RITE AID Acetaminophen Extended-Release Tablets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  EXTENDED RELEASE
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6690
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	511
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-6690-0	1 in 1 BOX	08/12/2019
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 11822-6690-1	1 in 1 BOX	08/12/2019
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 11822-6690-5	225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207035	08/12/2019

Labeler - Rite Aid Corporation (014578892)