Major Pharmaceuticals Anti-diarrheal Drug Facts

Major Pharmaceuticals Anti-diarrheal Drug Facts
SPL v2
SPL
SPL Set ID f4c23673-056e-7608-e053-2995a90a9276
Route
ORAL
Published
Effective Date 2019-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Anhydrous Lactose Carnauba Wax D&c Yellow No. 10 Fd&c Blue No. 1 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: L2 Shape: oval Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2003-02-24

Description

Loperamide HCl 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

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 HCl

Heart alert: Taking more than directed can cause serious heart problems or death

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; 1/2 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; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

children 2-5 years

(34 to 47 lbs)

ask a doctor

children under 2 years

(up to 33 lbs)

do not use

Do Not Use

if you have bloody or black stool

Other Information
  • store at 20 °-25 °C (68 °-77 °F)
  • see end panel for lot number and expiration date
Inactive Ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions Or Comments?

1-800-719-9260

Principal Display Panel

See New Warnings

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal Controls the Symptoms of Diarrhea

Actual Size

12 CAPLETS*

*Capsule-Shaped Tablets

COMPARE TO active ingredient of IMODIUM ® A-D

When Using This Product

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

Stop Use and Ask A Doctor If
  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • 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).

Active Ingredient (in Each Caplet)

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm
Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Loperamide may interact with certain prescription drugs.


Structured Label Content

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

Anti-diarrheal

Warnings

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

Heart alert: Taking more than directed can cause serious heart problems or death

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; 1/2 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; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

children 2-5 years

(34 to 47 lbs)

ask a doctor

children under 2 years

(up to 33 lbs)

do not use

Do Not Use (Do not use)

if you have bloody or black stool

Other Information (Other information)
  • store at 20 °-25 °C (68 °-77 °F)
  • see end panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

See New Warnings

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal Controls the Symptoms of Diarrhea

Actual Size

12 CAPLETS*

*Capsule-Shaped Tablets

COMPARE TO active ingredient of IMODIUM ® A-D

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging. These may be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Loperamide may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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