NDC | 58602-161-33 |
Set ID | 4407c31f-6a50-4a58-81d1-81c537529c17 |
Category | Human OTC Drug Label |
Packager | Aurohealth LLC |
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
- 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
- When using this product
-
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.
-
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
-
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:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648 -
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)
AUROHEALTH
Compare to the active ingredients in Theraflu® ExpressMax™ Nighttime Severe Cold & Cough*
NDC 58602-161-33
AuroFlu
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% -
INGREDIENTS AND APPEARANCE
AUROFLU NIGHT TIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-161 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:58602-161-33 245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/09/2016 08/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/09/2016 08/01/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-161)