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 Fred's, 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: Fred's, Inc.
4300 NEW GETWELL RD
MEMPHIS, TN38118
www.fredsinc.com

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

freds
Pharmacy

NDC: 55315-004-33

Nighttime
SEVERE COLD
& COUGH
Maximum Strength Per 4 Hour Dose

Each dose (per 30 mL) of Syrup contains:
650 mg - ACETAMINOPHEN, USP
(Pain Reliever/Fever Reducer)
25 mg - DIPHENHYDRAMINE HCl, USP
(Cough Suppressant/Antihistamine)
10 mg - PHENYLEPHRINE HCl, USP
(Nasal Decongestant)

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

8.3 FL OZ (245.5 mL)

Berry Flavor
Alcohol Content: 10%

Compare to the Active Ingredients In
Theraflu® ExpressMaxTM
Nighttime Severe Cold&Cough*

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: 55315-004
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)
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: 55315-004-33	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 - Fred's, Inc. (005866116)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(55315-004)