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  5. Label Information: Diabetic Tussin Nighttime Cold And Flu

FDA Label for Diabetic Tussin Nighttime Cold And Flu

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML)
    2. PURPOSES
    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
    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

Diabetic Tussin Nighttime Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Health Care Products. 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)



Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Diphenhydramine HCl 12.5 mg


Purposes



Pain Relief

Cough Suppressant

Antihistamine


Uses



temporarily relieves common cold/flu symptoms including:

  • •cough due to minor throat and bronchial irritation
  • •sore throat
  • •headache
  • •minor aches and pains
  • •muscular aches
  • •fever
  • •runny nose and sneezing

Warnings



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

  • •adults take more than 6 doses in 24 hours, which is the maximum daily amount
  • •child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • •taken with other drugs containing acetaminophen
  • •adult has 3 or more alcoholic drinks everyday while using this product

    • Sore throat warning: If sore throat is severe, persists for more than two 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.
  • •with any other product containing diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have



  • •liver disease
  • •glaucoma
  • •a breathing problem such as emphysema or chronic bronchitis
  • •trouble urinating due to enlargement of the prostate gland
  • •cough that occurs with too much phlegm (mucus)
  • •a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use



if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.


When Using This Product:



  • •you may get very drowsy
  • •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 small children

Stop Use And Ask A Doctor If



  • •redness or swelling is present
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •cough lasts more than 7 days, comes back, or occurs with fever, 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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.


Directions



  • •take every 4 to 6 hours
  • •do not exceed more than 5 doses in 24 hours for children under 12 years of age
  • •do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age

    • adults & children 12 years & over

    10 mL (2 teaspoonfuls)

    children 6 years to under 12 years

    5 mL (1 teaspoonful)

    children under 6 years

    ask a doctor


Other Information



  • •Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • •Store at room temperature 20-25°C (68-77°F)

Inactive Ingredients



Acesulfame potassium, aspartame, citric acid, hypromellose, menthol, methylparaben, natural & artificial orange flavor, polyethylene glycol, potassium sorbate, propylene glycol, purified water. Sodium citrate may be used to adjust pH.


Questions Or Comments?



Call: 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Rev. 452:04 12/11


Package/Label Principal Display Panel



Image of Carton - 118 mL - dad732cb 4936 433c 9bb0 5a0267f8e46c 01

Image of Carton - 118 mL - dad732cb 4936 433c 9bb0 5a0267f8e46c 01

NDC 61787-452-04

Diabetic Tussin®

DECONGESTANT FREE

Nighttime

Cold & Flu

FEVER, HEADACHE

BODY ACHES

COUGHS

SNEEZING

RUNNY NOSE

Liquid

NO

Sodium

Sorbitol

Fructose

& Dyes

ACETAMINOPHEN

DEXTROMETHORPHAN HBr

DIPHENHYDRAMINE HCl

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

 

4 FL OZ (118 mL)

 

 


* Please review the disclaimer below.