NIGHT TIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup

Night Time Severe Cold and Cough by

Drug Labeling and Warnings

Night Time Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Family Dollar, Inc., Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each 30 mL (2 TBSP))

Acetaminophen, USP 650 mg
Diphenhydramine HCl, USP 25 mg
Phenylephrine HCl, USP 10 mg

Purposes

Pain Reliever/Fever Reducer
Antihistamine/Cough suppressant
Nasal decongestant

Uses

• temporarily relieves these symptoms due to a cold:
• minor aches and pains
• minor sore throat pain
• headache
• nasal and sinus congestion
• runny nose
• sneezing
• itchy nose or throat
• itchy, watery eyes due to hay fever
• cough due to minor throat and bronchial irritation
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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 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

• in a child under 12 years of age
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on the skin
• 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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• pain, cough or nasal congestion gets worse or lasts more than 7 days
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
• measure the dose correctly using the enclosed dosing cup
• take every 4 hours in dosing cup provided, while symptoms persist
• do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor
• TBSP = Tablespoon, mL = milliliter

• Age: Dose
• adults and children 12 years of age and over: 30 mL (2 TBSP)
• children under 12 years of age: do not use

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• each 30 mL contains: potassium 9 mg, sodium 15 mg
• Store at 20-25oC (68-77oF)
• TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing

Inactive ingredients

acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue no.1, FD&C Red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

1-855-274-4122

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® ExpressMax™ Nighttime Severe Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: 
MIDWOOD BRANDS, LLC
500 Volvo Parkway Chesapeake, VA 23320
MADE IN USA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)

COMPARE TO THE ACTIVE INGREDIENTS OF THERAFLU® EXPRESSMAXTM NIGHTTIME SEVERE COLD & COUGH*

FAMILY wellnessTM
Severe Cold & Cough

BERRY FLAVOR

NIGHTTIME

Acetaminophen, USP (Pain Reliever/Fever Reducer)
Diphenhydramine HCl, USP (Cough Suppressant/Antihistamine)
Phenylephrine HCl, USP (Nasal Decongestant)

For Relief of: 

• Nasal Congestion
• Headache
• Sore Throat Pain
• Cough
• Body Ache
• Fever
• Runny Nose

Alcohol Content: 10%
MAXIMUM STRENGTH
PER 4 HOUR DOSE
OTC
 network
8.3 FL OZ (245.5 mL)

INGREDIENTS AND APPEARANCE

NIGHT TIME SEVERE COLD AND COUGH 
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-977
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BERRY (UNII: FV3431923Z)
PINEAPPLE (UNII: 2A88ZO081O)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED (Red Colored Liquid)	Score
Shape		Size
Flavor	BERRY, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-977-33	245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/09/2016

Labeler - Family Dollar, Inc. (024472631)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(55319-977)