ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

Arthritis Pain Reliever by

Drug Labeling and Warnings

Arthritis Pain Reliever by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)
Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

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 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.

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 (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.

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

• Supplied as unit dose packages of 30 (5 x 6) NDC: 68084-777-25
• store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F).
• FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

• about Acetaminophen, USP 650 mg call Ranbaxy Pharmaceuticals, Inc. at 1-800-406-7984
• about the packaging call American Health Packaging at 1-800-707-4621

Contains No Aspirin

PACKAGING INFORMATION
American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows:
(650 mg / 30 UD) NDC: 68084-777-25 packaged from NDC: 51660-333

Distributed by: American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217

8277725/0216OS

Principal Display Panel – Carton – 650 mg

NDC 68084- 777-25

Acetaminophen
Extended-release Tablets, USP
Pain Reliever/Fever Reducer

650 mg

30 Tablets (5 x 6)

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN.

Drug Facts

Active Ingredient Purpose

(in each caplet)
Acetaminophen USP, 650 mg Pain reliever/fever reducer

Uses
See package insert for complete Drug Facts information.

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.

Keep out of reach of children.

See package insert for additional Drug Facts warnings.

Directions
do not take more than directed, see package insert for
overdose warning and complete Drug Facts information.
Other Information store at 20° to 25°C (68° to
77°F). Avoid excessive heat 40°C (104°F). FOR YOUR
PROTECTION: Do not use product if blister is torn or
broken.

Contains No Aspirin

The drug product contained in this package is
from NDC # 51660-333, Ohm Laboratories Inc.

Distributed by: American Health Packaging,
2550 John Glenn Avenue, Suite A, Columbus,
OH 43217

077725
0277725/0216OS

Principal Display Panel – Blister – 650 mg

Acetaminophen
Extended-release
Tablet, USP
Pain Reliever/
Fever Reducer
650 mg

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEVER 
acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68084-777(NDC:51660-333)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Capsule Shaped)	Size	19mm
Flavor		Imprint Code	cor116
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68084-777-25	30 in 1 BOX, UNIT-DOSE	08/18/2014
1	NDC: 68084-777-95	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076200	08/18/2014

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(68084-777)