Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Good Remedies Allergy Relief Tablet
FDA Label NDC 70692-022
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 Allergy Relief (NDC 70692-022). 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 tablet), purpose, uses, 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
Antihistamine
Uses
■ temporarily relieves these symptoms due to hay fever or upper respiratory allergies:
■ runny nose ■ sneezing
■ itchy, watery eyes ■ itching of the nose or throat
■ temporarily relieves these symptoms due to the common cold:
■ runny nose ■ sneezing
Warnings
Do not use
■ to make a child sleepy
■ with other products containing diphenhydramine, even ones 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
■ marked drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
■ excitability may occur, especially in children
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
■ take every 4 to 6 hours, or as directed by doctor
■ do not take more than 6 times in 24 hours
| adults and children 12 years and over | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | do not use |
Other Information
■ each tablet contains: calcium 21 mg
■ store at room temperature between 20 - 25°C (68-77°F)
■ avoid excessive heat, cold and humidity
■ close cap tightly after use
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, D&C red no. 27, 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 Benadryl®Allergy Ultratabs®*
• Sneezing
• Itchy, watery eyes
• Runny nose
• Itchy throat
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Benadryl® Allergy Ultratabs®
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 Allergy Relief 70692-022-06 (70692 022 06)
* Please review the disclaimer below.
