Only For
FDA Label NDC 73006-113

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O4 Global Trading Usa, Llc for the product Only For (NDC 73006-113). 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 tablet), purpose, uses:, warnings:, 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 Tablet)

Chlorpheniramine Maleate 4mg

Purpose

Antihistamine

Uses:

  • temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Warnings:

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

    • Do not take if
    you are taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

      • If pregnant or breast-feeding,
      ask a health professional before use.

Keep Out Of Reach Of Children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

  • take with a full glass of water
  • Do not take more than directed
    •  adults and children 12 years of age and over 1 tablet every 4 to 6 hours, do not take more than 6 tablets in 24 hours
     children 6 to under 12 years of age ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours.
     children under 6 years of age ask a doctor

Other Information:

  • Store at room temperature between 20-25°C (68-77°F).
  • protect from excessive heat and moisture

Inactive Ingredients:

D&C yellow#10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

Questions Or Comments ?

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