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 Chain Drug Consortium, LLC, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts Active ingredients

Active ingredients
(in each tablespoonful 15 mL)

Acetaminophen 325 mg
Diphenhydramine HCL  12.5 mg
Phenylephrine HCL 5mg

Purpose

Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant

Keep out of reach of children

Keep out of reach of children

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 warnings: This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 6 dose in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Warnings

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 taking  a prescription monamine 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
• with any other drug containing diphenhydramine, even one used on the skin
  
• for children under 4 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
• 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, sedatives, and tranquilizers may increase drowsiness
• avoid alcohol drinks
• be careful 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 persistent headache. These could be signs of a serious condition.

If pregnant or breast feeding

ask a health professional before use.

Overdose warning

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

Directions

Age                                                                                  Dose

Children under 4 years                                                      Do not use

Children 4 to under 12 years of age                                    Do not use unless directed by a doctor

Adults and children 12 years and over                                2 tablespoonful (30 mL) every 4 hours

• take only as recommended (see Overdose warning)
• use dose cup or tablespoon (TBSP)
• do not take more than 6 doses in any 24-hour period

Other information

• each tablespoon (15 mL) contains:  potassium 9 mg, sodium 6 mg
• dosage cup provided
• store between 20°-25° C (68°-7°7 F)
• do not refrigerate

Inactive ingredients

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and 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

Product Label

NDC: 6801-154-08

*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION

Premier Value®

Night Time Severe Cold and Cough Relief

Acetaminophen ............ Pain Reliever/Fever Reducer
Diphenhydramine.......... Antihistamine/Cough Suppressant
Phenylephrine HCL ...... Nasal Congestion

    Fever and Body Aches
    Sore Throat
    Headache
    Nasal Congestion
    Runny Nose
    Cough

   Cherry Flavor

8.3 FL OZ (245 mL)

PV  Independently Tested Satisfaction Guaranteed

LF-007

DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING
Failure to follow these warnings could result in consequences

LB-007

DISTRIBUTED BY CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD SUITE 101
BOCA RATON, FL 33431

Lot:
Exp:

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

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: 68016-154
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 HYDROCHLORIDE	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 (CHERRY FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-154-08	245 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/04/2013

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-154)