NITETIME COUGH by KINGSTON PHARMA LLC NITETIME COUGH liquid

NITETIME COUGH by

Drug Labeling and Warnings

NITETIME COUGH by is a Otc medication manufactured, distributed, or labeled by KINGSTON PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg

PURPOSE

Purpose:
Pain reliever/fever reducer
Cough suppressant
Antihistamine

INDICATIONS & USAGE

Uses

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

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.

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.
• To make a child sleep.

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

Ask a doctor before use if you have

• Glaucoma
• 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 sedatives or tranquilizers
• Taking the blood thinning drug warfarin

WHEN USING

When using this product

• Do not exceed recommended dosage
• Excitability may occur especially in children
• Marked drowsiness may occur
• Avoid alcoholic drinks
• Alcohol, sedatives and tranquilizers may increase drowsiness
• Be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

• 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

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions:

• Do not take more than directed.
• 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 6 hours.
• Children 4 to under 12 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 15-30 degree Celsius (59-86 degree Fahrenheit)
• Each tablespoon contains: Sodium 46mg

INACTIVE INGREDIENT

Inactive ingredients: Alcohol, Anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sodium citrate and Purified Water.

HOW SUPPLIED

(packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NITETIME COUGH 
nitetime cough liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71027-041
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYL SALICYLATE (UNII: LAV5U5022Y)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71027-041-06	1 in 1 CARTON	03/01/2017
1		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2017

Labeler - KINGSTON PHARMA LLC (080386521)

Registrant - KINGSTON PHARMA LLC (080386521)

Establishment
Name	Address	ID/FEI	Business Operations
KINGSTON PHARMA LLC		080386521	manufacture(71027-041)