NDC | 46122-359-30 |
Set ID | 53b5e704-b3eb-4b1b-9463-a80edf8dcb18 |
Category | Human OTC Drug Label |
Packager | Amerisource Bergen |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Purposes
- Uses
-
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
- When using this product
-
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,
-
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
- Inactive ingredients
- Questions or Comments
-
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 solutionProduct 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 07/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/23/2016 07/22/2022 Labeler - Amerisource Bergen (007914906) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(46122-359)