1. Home
  2. Labeler Index
  3. Dolgencorp, Llc
  4. 55910-719
  5. Label Information: Dg Health Cold Max

FDA Label for Dg Health Cold Max

View Indications, Usage & Precautions

Table of Contents

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

Dg Health Cold Max Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, 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 15 Ml)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


Uses



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

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • •skin reddening
    • •blisters
    • •rash

      • If a skin reaction occurs, stop use and seek medical help right away.

      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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • •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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients

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
  • •a breathing problem such as emphysema or chronic bronchitis
  • •glaucoma
  • •persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • •cough that occurs with too much phlegm (mucus)

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 exceed recommended dose
  • •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.



Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 overdose warning)
  • •mL = milliliter
  • •use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • take 30 mL in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL in 24 hours, unless directed by a doctor

    adults and children 12 years and over

    ••

    children under 12 years

    ask a doctor


Other Information



  • •each 15 mL contains: sodium 5 mg
  • •store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive Ingredients



anhydrous citric acid, FD&C blue no. 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose


Questions Or Comments?



1-888-309-9030


Package/Label Principal Display Panel



Compare to the active ingredients of Tylenol® Cold Max

Night Time

Cold Max

Acetaminophen, Phenylephrine HCl

Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever, Fever Reducer, Nasal Decongestant

Cough Suppressant, Antihistamine

Headache – Fever – Sore throat

Nasal congestion – Cough – Runny nose

For adults

8 FL OZ (240mL)

Cool Ice®


* Please review the disclaimer below.