FAST MAXIMUM NIGHT TIME COLD AND FLU- acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride solution

Fast Maximum Night Time Cold and Flu by

Drug Labeling and Warnings

Fast Maximum Night Time Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 20 mL (4 tsp) dose)

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

Purposes

Pain reliever/fever reducer
Antihistamine/cough suppressment
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
• temporarily reduces fever
• controls cough to help you get to sleep 

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

• 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 drug 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.
• for children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredients Avoid foods or beverages that contain caffeine

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
• glaucoma
• breathing problems such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or 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
• you are taking sedatives or tranquilizers

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur

• alcohol, sedatives, and tranquilizers may increase drowsiness

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• pain, nasal congestion, or cough gets worse, or lasts more than 7 days
• fever gets worse, or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back, or occurs with fever, 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 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 (1-800-222-1222). 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 take more than directed (see Overdose warning)
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• mL = milliliter; tsp = teaspoon
• adults and children 12 years of age and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
• children under 12 years of age: do not use unless directed by a doctor

Other information

• Each 20 mL contains: sodium 12 mg
• tamper evident: do not use if printed seal under cap is torn or missing
• Store at 20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue, FD&C Red, flavors, glycerin, noncrystallizing sorbitol solution, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

Questions or Comments

1-855-274-4122

You may also report side effects to this phone number.

Distributed by:
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)

NDC: 46122-359-30

Compare to Mucinex®
FAST-MAX®
NIGHTTIME COLD & FLU
active ingredients*

GOOD
NEIGHBOUR
PHARMACY®

MAXIMUM STRENGTH**
Fast Maximum
Night Time Cold & Flu
 

Each dose 20 mL (4 tsp) of oral solution contains:

650 mg - acetaminophen USP (pain reliever/fever reducer)

25 mg - diphenhydramine HCl USP (antihistamine/cough suppressant)

10 mg - phenylephrine HCl USP (nasal decongestant)

• Relieves Aches, Fever & Sore Throat
• Controls Cough
• Relieves Nasal Congestion
• Relieves Runny Nose & Sneezing 

For Ages 12+           6 FL OZ (180 mL)

INGREDIENTS AND APPEARANCE

FAST MAXIMUM NIGHT TIME COLD AND FLU 
acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-359
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
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)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE (Blue to Bluish Green)	Score
Shape		Size
Flavor	BERRY, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-359-30	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/23/2016

Labeler - Amerisource Bergen (007914906)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(46122-359)