Anti-diarrheal, 12ct, 24/7 Life By 7-eleven ™

Anti-diarrheal, 12ct, 24/7 Life By 7-eleven ™
SPL v1
SPL
SPL Set ID 37ed75fd-fa8d-2a52-e063-6294a90a7009
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Microcrystalline Cellulose Starch, Corn Magnesium Stearate Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: oval Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2022-09-14

Description

Active ingredient (in each caplet) Loperamide HCl 2 mg

Purpose

​Purpose Anti-diarrheal


Medication Information

Purpose

​Purpose

Anti-diarrheal

Description

Active ingredient (in each caplet) Loperamide HCl 2 mg

Use

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Warnings

Directions

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 (34-47 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.

Heart Alert

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

Pdp/package

[24/7 Life by 7-Eleven logo]

Anti-Diarrheal

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal



Controls the Symptoms

of Diarrhea

compare to

Imodium ® AD

active ingredient*

12

CAPLETS

[caplet image]

Actual Size

Ask A Doctor

Ask a doctor before use if you have

  • a fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm
Allergy Alert

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

Active Ingredient

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Other Information

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

Questions or comments? call 1-877-507-6516 (M-F 8:00 AM - 4:30 PM CST)

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

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.

Ask A Doctor Or Pharmacist Before Use

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

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

​Purpose

Anti-diarrheal

Warnings

Warnings

Directions

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 (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use

Do Not Use (Do not use)

Do not use if you have bloody or black stool.

Heart Alert (Heart alert)

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

Pdp/package (PDP/Package)

[24/7 Life by 7-Eleven logo]

Anti-Diarrheal

Loperamide HCl Tablets, 2 mg

Anti-Diarrheal



Controls the Symptoms

of Diarrhea

compare to

Imodium ® AD

active ingredient*

12

CAPLETS

[caplet image]

Actual Size

Ask A Doctor (Ask a doctor)

Ask a doctor before use if you have

  • a fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm
Allergy Alert (Allergy alert)

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

Active Ingredient (Active ingredient)

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Other Information (Other information)

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments? (Questions or comments?)

Questions or comments? call 1-877-507-6516 (M-F 8:00 AM - 4:30 PM CST)

When Using This Product (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 (Stop use and ask a doctor)

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)

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children (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.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

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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