Extra Strength Back and Body description, usages, side effects, indications, overdosage, supplying and lots more!

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Extra Strength Back and Body

L.N.K. International, Inc.

Quality Plus 44-413


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg (NSAID)*
Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever
Pain reliever aid 

Extra Strength Back and Body Uses

for the temporary relief of:

  • backache pain
  • muscle aches and pains
  • minor aches and pains of arthritis 

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. 

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

Stomach bleeing warning: This product contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

  • have had stomach ulcers or bleeding problems, are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have asthma
  • you have high blood pressure, heart disease, lover cirrhosis, or kidney disease
  • you are taking a diuretic 

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • an allergic reaction occurs.  Seek medical help right away.
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition. 

If pregnant or breast-feeding,

ask a health professional before useIt is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hour
  • children under 12 years: do not use unless directed by a doctor 

Extra Strength Back and Body Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate 

Questions or Comments?

1-800-426-9391 

Principal display panel

NDC 50844-413-08

†Compare to the active ingredient in Bayer® Back and Body

QUALITY PLUS

Extra Strength
Back and Body
Aspirin (NSAID) & Caffeine
Pain Reliever/Pain Reliever Aid
Fast Pain Relief at the site of Pain

24 Coated Caplets

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Back and Body.
50844    ORG011341308

Distributed by: LNK INTERNATIONAL INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

Extra Strength Back and Body
Quality Plus 44-413

Extra Strength Back and Body

Aspirin, Caffeine CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50844-413
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 500 mg
CAFFEINE 32.5 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM LAURYL SULFATE
POLYETHYLENE GLYCOLS
HYPROMELLOSES
STARCH, CORN
maltodextrin

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm 44;413 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 NDC:50844-413-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-04-12


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Be sure to consult your doctor before taking any medication!
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