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Daytime Cough

Medically reviewed on March 1, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: KINGSTON PHARMA LLC
NDC Code: 71027-040

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Daytime Cough

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

Purpose: Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

  • Temporarily relieves these common cold/flu symptoms
    1. Minor aches and pains
    2. Headache
    3. Sore throat
    4. Nasal congestion
    5. Fever
    6. Cough due to minor throat and bronchial irritation

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.

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.

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

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

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.

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

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

Other information

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

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.

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

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

DAYTIME COUGH 
daytime cough liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-040
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
EDETATE DISODIUM 
FD&C YELLOW NO. 6 
METHYL SALICYLATE 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SUCROSE 
XANTHAN GUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:71027-040-061 BOTTLE in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2017
Labeler - KINGSTON PHARMA LLC (080386521)
Registrant - KINGSTON PHARMA LLC (080386521)
Establishment
NameAddressID/FEIOperations
KINGSTON PHARMA LLC080386521manufacture(71027-040)

 
KINGSTON PHARMA LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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