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pain relief

Safeway

Safeway Inc. Pain Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

pain relief Uses

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

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 for more than 10 days
  • fever gets worse or lasts for 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: Taking more than the recommended dose (overdose) may cause liver damage. 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 and children 12 years and over
  • take 2 caplets every 8 hours with water
  • swallow whole – do not crush, chew 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
children under 12 years
  • do not use

pain relief Other information

  • store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).
  • see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-888-SAFEWAY

Principal Display Panel

Compare to Tylenol® 8 Hour active ingredient

8 Hour

Pain Relief

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever / Fever Reducer

For up to 8 Hour Relief of Minor Muscular Aches & Pain

ACTUAL SIZE

SEE NEW WARNINGS INFORMATION

*Take only as directed

*Capsule-Shaped Tablets


pain relief
Pain Relief Carton Image 1 Pain Relief Carton Image 2

pain relief

Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-217
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
polyethylene glycol 400
polysorbate 80
povidone
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 19 mm L217 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:21130-217-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075077 2010-11-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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