NDC | 58602-127-20 |
Set ID | b6727737-41db-42fe-b82e-696d92afff71 |
Category | Human OTC Drug Label |
Packager | Aurohealth LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Purpose
- 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 every day 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.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
-
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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
- 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 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 rash or headache that lasts.
These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- do not take more than directed (see overdose warning)
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- mL = milliliter
adults and children 12 years and over - take 30 mL in the dosing cup provided every 4 hours while symptoms last
- do not take more than 150 mL in 24 hours, unless directed by a doctor
children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or Comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL Bottle)
AUROHEALTH
NDC 58602-127-20Compare to the active
ingredients in TYLENOL®
COLD MULTI-SYMPTOM Liquid night time cool burstTM*NIGHT TIME
Cool Blast
AUROPHEN
COLD MULTI-SYMPTOM
For Adults
Acetaminophen - Pain Reliever/Fever Reducer
Phenylephrine HCl - Nasal Decongestant
Dextromethorphan HBr - Antitussive
Doxylamine Succinate - Antihistamine
- Headache, Fever, Sore Throat
- Nasal Congestion
- Cough
- Runny Nose Alcohol 0.5%
8 FL OZ
(240 mL)
Liquid
Do not use if printed shrinkband is missing or broken.
-
INGREDIENTS AND APPEARANCE
AUROPHEN COLD MULTI SYMPTOM
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-127 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PEPPERMINT (UNII: V95R5KMY2B) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color BLUE (Blue to greenish blue) Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-127-20 1 in 1 CARTON 04/30/2015 03/01/2022 1 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/30/2015 03/01/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-127)