INTESTINOMICINA- loperamide hci, simethicone capsule 
Procaps S.A. de C.V.

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Intestinomicina AD+

Drug Facts

Active ingredients (in each caplet) & Purposes

.

Active ingredients (in each caplet)Purposes
Loperamide HCI 2 mg .............Anti-diarrheal
Simethicone 125 mg ...............Anti-gas

Uses

Relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.

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

Do not use

  • if you have bloody or black stool
  • if you have difficulty swallowing

Ask a doctor before use if you have

  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abdominal heart rythm

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug. Loperamide interact with certain prescriptions 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
  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging. These may be signs of a serious condition.
  • you have difficulty swallowing the caplet

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
  • take only on an empty stomach (1 hour before or 2 hours after a meal)
  • take with a full (8 oz.) glass of water
  • find right dose on chart below. 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 2-5 years

(34 to 47 lbs)

ask a doctor

children under 2 years

(up to 33 lbs)

do not use

Other information

  • each caplet contains: calcium 180 mg, sodium 3 mg
  • store between 20 °-25 °C (68 °-77 °F). Protect from light.
  • do not use if printed blister unit is broken or torn

Inactive ingredients

acesulfame potassium, colloidol silicone dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Questions or comments?

call 1-754-260-6474 (Monday - Friday 8 am - 4 pm)

Package/Label Principal Display Panel

Intestinomicina ADplus_PDPi

INTESTINOMICINA 
loperamide hci, simethicone capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76864-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULESize16mm
FlavorCARAMEL ((Caramel Vanilla)) Imprint Code 2;63
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76864-100-1212 in 1 CARTON07/08/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21454107/04/2018
Labeler - Procaps S.A. de C.V. (851259341)

Revised: 6/2022
Document Id: e2877488-3537-cba2-e053-2995a90a6005
Set id: e2877488-3538-cba2-e053-2995a90a6005
Version: 1
Effective Time: 20220627
 
Procaps S.A. de C.V.