FDA Label for Good Remedies Nighttime Sleep Aid Caplets
View Indications, Usage & Precautions
Good Remedies Nighttime Sleep Aid Caplets Product Label
The following document was submitted to the FDA by the labeler of this product Strive Pharmaceuticals 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.
Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep aid
Use
• for relief of occasional sleeplessness
Warnings
Do not use
• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
• avoid alcoholic drinks
• drowsiness will occur
• do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of serious underlying medical illness.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years and over | take 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years | do not use |
Other Information
• each caplet contains: calcium 22 mg
• store at room temperature between 20°-25°C (68°-77°F)
• protect from light, heat and moisture
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1, FD&C blue no. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
Questions Or Comments?
1-888-577-8033 Monday - Friday 8am - 4pm EST
Other
Compare to the active ingredient of TYLENOL PM® Simply Sleep®*
Helps you fall asleep
Safe, non-habit forming
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademarks Tylenol PM® and Simply Sleep®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Strive Pharmaceuticals Inc.,
East Brunswick, NJ 08816
PRODUCT OF INDIA
Packaging
* Please review the disclaimer below.
