FDA Label for Calmco Sleep Aid
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT AND PURPOSE
- OTC - PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Calmco Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Calmco Llc. 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.
Drug Facts
.
Active Ingredient And Purpose
.
Otc - Purpose
| Active ingredient (in each 10 mL vial) | Purpose |
| Diphenhydramine HCl 25 mg............... | Nighttime sleep-aid |
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
.
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- on children under 12 years of age
Ask A Doctor Before Use If You
- have a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- have trouble urinating due to an enlarged prostate gland
- are taking sedatives or tranquilizers
When Using This Product
avoid consuming alcohol beverages
Stop Use And Ask A Doctor If
- sleeplessness persists continuously for more than 2 weeks.Insomnia may be a symptom of a serious underlying medical illness.
If Pregnant Or Breastfeeding,
ask a healthcare professional before use
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- do not take more than directed
- follow the “Easy to Use” instructions on pouch
| Age | Dose |
| Adults and children 12 years and older | take 2 vials at bedtime, if needed |
| children under 12 years | do not use |
Other Information
- each 10 mL vial contains: sodium 4 mg
- store between 68-77°F (20-25°C)
- do not use if pouch has been torn open or vial is punctured or open
Inactive Ingredients
Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, water, xylitol
Questions Or Comments?
+1 941-203-4590 (M-F) 9am-5pm EST or visit www.calmco.com
Distributed by: CalmCo LLC, Sarasota, FL 34240
Made in Dominican Republic
* Please review the disclaimer below.
