Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Good Remedies Nighttime Sleep Aid Caplets Tablet
FDA Label NDC 70692-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Good Remedies Nighttime Sleep Aid Caplets (NDC 70692-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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?
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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
Good Remedies Sleep Aid 70692-011-06 (70692 011 06)
* Please review the disclaimer below.
