Allergy Relief Capsule
FDA Label NDC 72476-113

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services , Llc. for the product Allergy Relief (NDC 72476-113). 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 other, active ingredient (in each capsule), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Capsule)

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 due to the common cold:
      • runny nose
      • sneezing

Otc - Do Not Use

Do not use

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

Ask A Doctor Before Use If You Have

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

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 times in 24 hours
    • adults and children 12 years and over1 to 2 capsules
    children 6 to under 12 years1 capsule
    children under 6 yearsdo not use

Other Information

  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive Ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Principal Display Panel

CAREONE®

NDC 72476-113-01

Compare to the active ingredient in Benadryl® Allergy†

ALLERGY RELIEF

Diphenhydramine HCl, 25 mg

Antihistamine

FOR RELIEF OF:

• Sneezing

• Itchy, Watery Eyes

• Runny Nose

• Itchy Throat

Actual Size

24 CAPSULES

Image Description (F111301car R0)

Image Description (F111301car R0)

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