Active Ingredients (In Each Tablet)
Phenylephrine HCl 10 mg
Chlorpheniramine maleate 4mg
Cold And Allergy Tablet
FDA Label NDC 69168-406
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Cold And Allergy (NDC 69168-406). 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 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Decongestant
Antihistamine
Uses
temporarily relieves nasal congestion due to the common cold, and these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- sinus congestion and pressure
Do Not Use
if you are now taking a prescription monoamine oxadise 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- diabetes
- heart disease
- high blood pressure
- thyroid disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
- do not use more than directed
- may cause excitability, especially in children
- may cause drowsiness; alcohol, sedatives or tranquilizers may increase drowsiness
- avoid alcoholic beverages and use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.
Directions
Adults and children 12 years of age and older: 1 tablet every 4 to 6 hours. Do not take more than 6 doses in 24 hours
Children under 12 years of age: Consult a doctor
Other Information
- store at room temperature
- do not use if blister unit is torn or open
Inactive Ingredients
croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Package/Label Principal Display Panel
Cold and Allergy
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