Active Ingredient (In Each 1.1 Oz Pouch)
Diphenhydramine HCL 50mg.....................Nighttime sleep aid
Mantra Solution
FDA Label NDC 85410-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Moremed Inc. for the product Mantra (NDC 85410-040). 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 1.1 oz pouch), use(s), warnings, when using this product, do not use, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use(S)
Nighttime sleep-aid
Warnings
Do not use
for children under 12 years of age
with any other products 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 or difficulty in urinating due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers,
When using this product
avoid alcoholic 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 health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a poison control Centre right away.
When Using This Product
Avoid alcoholic beverages
Do Not Use
For children under 12 years of age
With any other products containing diphenhydramine, even one used on skin
Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a poison control Centre right away.
Directions
Take only one dose (1 Pouch) per day (24 hours)
Adults and children 12 years and over:1 Pouch at bedtime if needed, or as directed by a doctor
Other Information
Store at controlled room temperature
Avoid excessive heat above 40 °C (104 °F).
Protect from moisture.
Questions
Call 1-800-529-3182 (toll-free)
Mon-Fri 9 AM-5PM EST
Ask a doctor before use if you have diabetes
Indications & Usage
Helps to reduce difficulty falling asleep
Mantra
Nighttime Sleep Aid
Clean Sleep Gel
Mantra
+ Manuka Honey
Diphenhydramine HCL 50mg
Wild Cherry
Oral Solution
1 pouch NET WT.0.85 OZ (24 g)
Package Label.Principal Display Panel
Mantra (Mantra)
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