Daytime Cough by KINGSTON PHARMA LLC DAYTIME COUGH liquid

Daytime Cough by

Drug Labeling and Warnings

Daytime 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 10 mg
Phenylephrine HCl 5 mg

PURPOSE

Purpose: Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

INDICATIONS & USAGE

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

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

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 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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME COUGH 
daytime cough liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71027-040
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	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHYL SALICYLATE (UNII: LAV5U5022Y)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71027-040-06	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(71027-040)