Careone Allergy Relief Tablet
FDA Label NDC 41520-778

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Careone Allergy Relief (NDC 41520-778). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Do Not Use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask A Doctor Before Use If You Have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses 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 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.

Inactive Ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredient in Benadryl® Allergy Ultratabs®

Easy To Swallow

Allergy Relief

Diphenhydramine Hydrochloride Tablets, 25 mg Antihistamine

Actual Size

100 TABLETS

FOR ALLERGY RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

Gluten Free

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479-of-allergy-relief.jpg (479 Of Allergy Relief)

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