FDA Label for Cold And Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Cold And Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product H E B. 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 Tablet)
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- nasal congestion
- itching of the nose or throat
- itchy, watery eyes
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion
Do Not Use
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
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- do not use more than directed
- excitability may occur, especially in children
- 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
- nervousness, dizziness, r sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4 hours
- do not take more than 6 doses in 24 hours
adults and children 12 years of age and older | take 1 tablet |
children 6 to under 12 years of age | take 1/2 tablet |
children under 6 years of age | consult a doctor |
children under 4 years of age | do not use |
Other Information
- each tablet contains: calcium 10 mg
- store between 15-30°C (59-86°F)
Inactive Ingredients
colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, sodium starch glycolate and stearic acid
Questions Or Comments?
Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Actifed® Cold & Allergy active ingredients**
Maximum Strength
COLD & ALLERGY RELIEF
Chlorpheniramine maleate 4 mg / Antihistamine
Phenylephrine HCl 10 mg / Nasal Decongestant
Allergy & Congestion
Relief of:
- Nasal Congestion
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
For Ages 6 Years and Older
Does Not Contain Pseudoephedrine
TABLETS
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Actifed® Cold & Allergy.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204
Product Label
H-E-B Cold & Allergy Relief
* Please review the disclaimer below.