1. Home
  2. Labeler Index
  3. Allegiant Health
  4. 69168-319
  5. Label Information: Cold Multi-symptom Night-time

FDA Label for Cold Multi-symptom Night-time

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?

Cold Multi-symptom Night-time Product Label

The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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



Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg


Purpose



Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant


Uses



temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sneezing and runny nose sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever


Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product


Sore Throat Warning



If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Do Not Use



with any other products containing acetaminophen (prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or pharmacistif 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 drugs. 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



liver disease heart disease high blood pressure thyroid disease diabetes trouble
urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma


Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin taking sedatives or tranquilizers


When Using This Product



do not use exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery


Stop Use And Ask A Doctor If



nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition


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 immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



■ do not take more than directed (see Warnings)
Adults and children 12 years and over: ■ take 2 caplets every 4 hours ■ do not take more than a total of 12 caplets in 24 hours
Children under 12 years: Do not use this adult product in children under 12 years of age. This will provide more than recommended dose (overdose) and may cause liver damage


Other Information



store between 15-30°C (59-86°F) do not use if blister is torn or open


Inactive Ingredients



colloidal silicone dioxide, corn starch, croscarmellose sodium, FD&C Blue #1, FD&C Lake Black, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide


Questions Or Comments?



Call toll free 1-888-952-0050


* Please review the disclaimer below.