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  5. Label Information: Daytime Cough

FDA Label for Daytime Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. HOW SUPPLIED

Daytime Cough Product Label

The following document was submitted to the FDA by the labeler of this product Kingston Pharma 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.

Otc - Active Ingredient



Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg


Otc - Purpose



Purpose: Pain reliever/fever reducer
Cough suppressant
Nasal decongestant


Indications & Usage



Uses

  • Temporarily relieves these common cold/flu symptoms
    • Minor aches and pains
    • Headache
    • Sore throat
    • Nasal congestion
    • Fever
    • Cough due to minor throat and bronchial irritation

Warnings



Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • Adult has 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.


Otc - Do Not Use



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.

    • TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.


Otc - Ask Doctor



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 sodium restricted diet

    • Ask a doctor or pharmacist before use if you are

    • Taking the blood thinning drug warfarin

Otc - When Using



When using this product

  • Do not exceed recommended dosage (see overdose warning)

    • Stop use and ask doctor if

    • Nervousness, dizziness or sleeplessness occur
    • Symptoms get worse or last more than 5 days (children) or 7 days (adults)
    • 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


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.
Overdose Warning: In case of accidental overdose, seek professional assistance or contact a Poison control center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Dosage & Administration



Directions:

  • Do not take more than directed. (see overdose warning)
  • Use enclosed dosing cup.
  • Do not take more than 4 doses in 24-hours.
  • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 4 hours.
  • Children 6 to under 12 years: take 1 tablespoon (TBSP) or 15 mL every 4 hours.
  • Children 4 to under 6 years: ask a doctor
  • Children under 4 years: do not use
  • When using other Daytime or Nite time products, carefully read each label to insure correct dosing

Storage And Handling



Other information

  • Store between 20-25 degree Celsius (68-77 degree Fahrenheit)
  • Each tablespoon contains: Sodium 50mg

Inactive Ingredient



Inactive ingredients: Butylated hydroxyanisole, Edetate disodium, FD&C yellow 6, flavor, Glycerin, Menthol, Monobasic sodium phosphate, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sucrose, Xanthan gum and Purified Water.


How Supplied



(packs: 4oz) Kingston NDC# 71027-040-06

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662


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