OTC Medication Information: Anti-Diarrheal

ANTI-DIARRHEAL- loperamide hydrochloride tablet
Geri-Care Pharmaceutical Corp

Active ingredient(in each caplet)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Uses

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

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

Do not use if you have bloody or black stool

Ask a doctor before use if you have

  • a fever
  • mucus present in your 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.

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.

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

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • see end flap for expiration date and lot number

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?

call 1-800-540-3765

package Label

1
(click image for full-size original)
ANTI-DIARRHEAL
loperamide hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-381
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MAGNESIUM STEARATE
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color green (light green) Score 2 pieces
Shape CAPSULE Size 7mm
Flavor Imprint Code 44375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-381-12 12 TABLET in 1 BOTTLE None
2 NDC:57896-381-24 24 TABLET in 1 BOTTLE None
3 NDC:57896-381-48 48 TABLET in 1 BOTTLE None
4 NDC:57896-381-96 96 TABLET in 1 BOTTLE None
5 NDC:57896-381-25 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57896-381-25)
6 NDC:57896-381-13 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57896-381-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076497 01/01/2006
Labeler — Geri-Care Pharmaceutical Corp (611196254)
Registrant — Geri-Care Pharmaceutical Corp (611196254)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 manufacture (57896-381)

Revised: 05/2021 Geri-Care Pharmaceutical Corp

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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