FDA Label for Imodium A-d
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 7.5 ML)
- PURPOSE
- USE
- ALLERGY ALERT
- HEART ALERT
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Imodium A-d Product Label
The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. 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.
Other
Drug Facts
Active Ingredient (In Each 7.5 Ml)
Loperamide HCl 1 mg
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
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
Otc - Do Not Use
Do not use if you have bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
- a history of liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking antibiotics
Otc - When Using
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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. (1-800-222-1222)
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.
- shake well before using
- use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- mL = milliliter
| adults and children 12 years and over | 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours |
| children 9-11 years (60-95 lbs) | 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours |
| children 6-8 years (48-59 lbs) | 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 30 mL contains: sodium 16 mg
- store between 20-25°C (68-77°F)
- do not use if printed inner or outer neckband is broken or missing.
Inactive Ingredients
anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-134-04
See New Warning
and Directions
Imodium®
A-D
Loperamide HCl, Anti-Diarrheal
1 mg per 7.5 mL
Anti-Diarrheal
Oral Solution
Controls the symptoms
of diarrhea
4 fl oz
(120 mL)
Mint Flavor
* Please review the disclaimer below.