FDA Label for Careone Allergy Relief

View Indications, Usage & Precautions

Careone Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product American Sales Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Capsule)



Cetirizine HCl 10 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

Do Not Use



if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.


Ask A Doctor Before Use If You Have



liver or kidney disease. Your doctor should determine if you need a different dose.


Ask A Doctor Or Pharmacist Before Use If You Are



taking tranquilizers or sedatives.


When Using This Product



  • •drowsiness may occur
  • •avoid alcoholic drinks
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



an allergic reaction to this product occurs. Seek medical help right away.


If Pregnant Or Breast-Feeding:



  • •if breast-feeding: not recommended
  • •if pregnant: 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



adults and children 6 years and over

one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor


Other Information



  • •store between 20-25°C (68-77°F)
  • •avoid high humidity and excessive heat above 40°C (104°F)
  • •protect from light
  • •do not use if printed foil under cap is broken or missing

Inactive Ingredients



butylated hydroxytoluene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredient in Zyrtec® Liquid Gels

24hr

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

Cetirizine Hydrochloride Capsules, 10mg

Antihistamine

25 LIQUID GELS**

Actual Size

**Liquid Filled Capsules

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

- Sneezing

- Runny Nose

- Itchy, Watery Eyes

- Itchy Throat or Nose

OUR PHARMACISTS RECOMMEND


* Please review the disclaimer below.