NIGHT TIME SEVERE COLD AND COUGH RELIEF- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Night Time Severe Cold and Cough Relief by

Drug Labeling and Warnings

Night Time Severe Cold and Cough Relief by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredients(in each tablespoonful, 15 mL)

Acetaminophen 325 mg

Diphenhydramine HCL 12.5 mg

Phenylephrine HCL 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

• minor aches and pains
• headache
• sore throat
• nasal and sinus congestion
• runny nose
• sneezing
• itchy watery eyes
• itchy nose or throat
• cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily reduces fever

Warnings

Liver warning This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 6 doses in 24 hours, which is the maxium daily amount
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If a 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.f you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other drug containing diphenhydramine, even one used on skin
• for children under 12 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking

• the blood thinning drug warfarin
• sedatives or tranquilizers

When using this product

• do not use more than directed
  (see overdose warning)
• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, seadtives, tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be carefuk when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• redness or swelling is present
• symptoms do not get better within 7 days or are accompanied by a fever
• 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 persistanr headache. 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.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not noitce any signs or symptoms.

Directions

• take only as recommended (see Overdose warnings)
• Use dosage cup or tablespoon (TBSP)
• Do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age Dose

Children under                               Do not use
12 years of age

Adults & children                            2 tablespoomsful
12 tears and over                        

Other information

• each tablespoonful (15 mL contains potassium 9 mg. sodium 6 mg
• dosage cup provided
• store between 20-25°C (68-77° F)
• do not refigerate

Inactive ingredients

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

Questions ?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Night Time Severe Cold & Cough Relief product label

DISCOUNT
drug
mart
FOOD FAIR

*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFLU® WARMING RELIEF NIGHT TIME SEVERE COLD & COUGH

LF-017

Night Time Senere Cold & Cough Relief

Acetaminophen ....................Pain Reliever /Fever Reducer
Diphenhydramine .................Antihistamine/ cough Suppressant       

Phenylephrine HCL ................Nasal Decongestant

• Fever & Body Aches
• Sore Throat
• Headache
• Nassal Decongestant
• Runny nose
• Cough

CHERRY FLAVOR

8.3 FL O (245 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

* This product is not manufactured or distributed by Novartis Consumer health Inc.,owne of the registered trademark Theraflu® Night Time.

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINIA, OHIO 44256

LB-017

Lot:
Exp:

INGREDIENTS AND APPEARANCE

NIGHT TIME SEVERE COLD AND COUGH RELIEF 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-534
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
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-534-30	245 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/04/2016

Labeler - Discount Drug Mart (047741335)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53943-534)