Loperamide Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Loperamide Hydrochloride

Fred's Inc.
Ranbaxy Pharmaceuticals Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT (IN EACH CAPLET)

Loperamide HCI USP, 2 mg

PURPOSE

Anti-diarrheal

USE

Controls symptoms of diarrhea, including Travelers’ Diarrhea

WARNINGS

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI

Do not use

If you have bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus in the stool
  • a history of liver disease

Ask a doctor or pharmacist before use if you are

Taking antibiotics

When Using this product

  • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • you get abdominal swelling or bulging. These may be signs of a serious condition.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children.

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

DIRECTIONS

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    adults and children 12 years and over 2 caplets after the first loose stool;
    1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
    children 9-11 years
    (60-95 lbs)
    1 caplet after the first loose stool;
    ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
    children 6-8 years
    (48-59 lbs)
    1 caplet after the first loose stool;
    ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
    children under 6 years
    (up to 47 lbs)
    ask a doctor

OTHER INFORMATION

  • store between 20° – 25° C (68° – 77° F)
  • see side panel for batch number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

INACTIVE INGREDIENTS

Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

QUESTIONS?

Call 1800-406-7984

PRINCIPAL DISPLAY PANEL

fred's ®

Loperamide Hydrochloride Tablets USP, 2 mg

Anti-Diarrheal

Controls The Symptoms of Diarrhea

24 CAPLETS*

Each Caplet (*capsule-shaped tablet)

contains Loperamide HCl USP, 2 mg

Compare to Active Ingredient of Imodium ® A-D

DISTRIBUTED BY: fred's Inc.

5091235/R1111

Loperamide Hydrochloride

Loperamide Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-123
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 2 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
TRISTEARIN
MAGNESIUM STEARATE
POWDERED CELLULOSE
STARCH, PREGELATINIZED CORN

Product Characteristics

Color Size Imprint Code Shape
green 9 mm 123 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-123-06 6 in 1 BLISTER PACK
2 NDC:55315-123-24 24 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074091 1993-02-01


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Be sure to consult your doctor before taking any medication!
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