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  5. Label Information: Health Mart Childrens Allergy Plus Congestion

FDA Label for Health Mart Childrens Allergy Plus Congestion

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Health Mart Childrens Allergy Plus Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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 Ingredients (In Each 5 Ml)



Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg


Purpose



Antihistamine

Nasal decongestant


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
  • •nasal congestion
  • •stuffy nose
  • •temporarily relieves these symptoms due to the common cold:
  • •runny nose
  • •sneezing
  • •nasal congestion
  • •stuffy nose
  • •temporarily relieves sinus congestion and pressure

Do Not Use



  • •to make a child sleepy
  • •with any other product containing diphenhydramine, even one used on skin
  • •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have



  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •trouble urinating due to an enlarged prostate gland
  • •a breathing problem such as emphysema or chronic bronchitis
  • •glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • •do not exceed recommended dose
  • •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

Stop Use And Ask A Doctor If



  • •nervousness, dizziness, or sleeplessness occur
  • •symptoms do not improve within 7 days or occur with a fever

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



  • •find right dose on chart below
  • •mL = milliliter
  • •take every 4 hours
  • •do not take more than 6 doses in 24 hours

    • Age (yr)

    Dose (mL)

    children under 4 years

    do not use

    children 4 to 5 years

    do not use unless

    directed by a doctor

    children 6 to 11 years

    5 mL

    adults and children 12 years and over

    10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


Other Information



  • •each 5 mL contains: sodium 10 mg
  • •store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
  • •do not use if printed neckband is broken or missing

Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Children’s Benadryl® Allergy Plus Congestion active ingredients

ORAL SOLUTION

Children’s Allergy Plus Congestion

Antihistamine (Diphenhydramine HCl)

Nasal Decongestant (Phenylephrine HCl)

Relieves:

Runny Nose; Sneezing

Itchy, Watery Eyes; Itchy Throat or Nose

Sinus Congestion; Stuffy Nose

4 Hours/Dose • Sugar Free

Gluten Free • Alcohol Free

GRAPE FLAVOR

4 Fl oz (118 mL)


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