Sunmark 8 hour pain relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Sunmark 8 hour pain relief

McKesson

McKesson 8 Hour Pain Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Sunmark 8 hour 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

Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

  • with any other product containing acetaminophen

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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. 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

Sunmark 8 hour pain relief Other information

  • do not use if printed foil under cap is broken or missing
  • 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?

1-800-719-9260

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 & PAINS

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

650 mg

*Capsule-shaped tablets

Sunmark 8 hour pain relief
8 Hour Pain Relief Carton Image 1 8 Hour Pain Relief Carton Image 2

Sunmark 8 hour pain relief

Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-705
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 50 in 1 BOTTLE
2 100 in 1 BOTTLE
3 NDC:49348-705-10 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075077 2005-08-30


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