Right Remedies Maximum Strength Nighttime Sleep-aid Softgel Capsule, Liquid Filled
FDA Label NDC 70692-834

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 Right Remedies Maximum Strength Nighttime Sleep-aid Softgel (NDC 70692-834). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - 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

Drug Facts

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

  • for relief of occasional sleeplessness
  • reduces time to fall alseep if you have difficulty falling asleep

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

    • Ask a doctor before use if you have

    • glaucoma
    • heart disease
    • a breathing problem such as emphysema, asthma, or chronic bronchitis
    • difficulty in urination due to an enlargement of prostate gland

      • Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

      When using this product

      • avoid alcoholic beverages and other drugs that cause drowsiness.
      • be careful when driving a motor vehicle or operating machinery.

        • 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 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 1 softgel (50mg) at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Other Information

  • store at room temperature between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light, heat and moisture

Inactive Ingredients

edible ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions Or Comments?

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Packaging

Nighttime834-2 (70692834 1)

Nighttime834-2 (70692834 1)

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