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  5. Label Information: Stomach Relief Anti Diarrheal

FDA Label for Stomach Relief Anti Diarrheal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. DOSAGE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. PREGNANCY
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INACTIVE INGREDIENT
    9. LABEL DISPLAY PANEL

Stomach Relief Anti Diarrheal Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Loperamide HCl 2 mg


Purpose



Anti Diarrheal


Dosage



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
under 6 years (up to 47 lbs): ask a doctor


Indications & Usage



• controls the 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

• if you have bloody or black stool Ask a doctor before use

• if you have: • fever • mucus in stool • a history of liver disease Ask a doctor or pharmacist before use

• if you are: • taking antibiotics 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


Pregnancy



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


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.


Inactive Ingredient



Inactive
Ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, DC yellow no. 10, FDC blue no. 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch


Label Display Panel



MM1


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