welmate anti-diarrheal (loperamide hcl) caplets

welmate anti-diarrheal (loperamide hcl) caplets
SPL v1
SPL
SPL Set ID ae2e006c-0347-6c35-e053-2a95a90ab7b1
Route
oral
Published
Effective Date 2020-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loperamide (2 mg)
Inactive Ingredients
starch, corn d&c yellow no. 10 aluminum lake dibasic calcium phosphate dihydrate fd&c blue no. 1 magnesium stearate microcrystalline cellulose silicon dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: oval Color: green Size: 8 mm Score: 2
Marketing Status
anda active Since 2020-08-22

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg


Medication Information

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.

Purpose

Anti-diarrheal

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

Other Information
  • do not use if blister unit is torn or open
  • store at 20°- 25°C (68° - 77°F)
Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel.

Description

Loperamide HCl 2 mg

Questions?

call toll-free 1-800-935-6737

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use:
  • if you have bloody or black stool
Package Labeling:

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 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 (1-800-222-1222) right away.

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 before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Structured Label Content

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.

Purpose

Anti-diarrheal

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

Other Information (Other information)
  • do not use if blister unit is torn or open
  • store at 20°- 25°C (68° - 77°F)
Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel.

Questions?

call toll-free 1-800-935-6737

Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Do Not Use: (Do not use:)
  • if you have bloody or black stool
Package Labeling:

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 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 (1-800-222-1222) right away.

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 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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