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![MULTI SYMPTOM COLD (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE, GUAIFENESIN) TABLET [HONEYWELL SAFETY PRODUCTS USA, INC]](https://medic.hrt.org//dailymed/images/9771b30a-15bc-420a-abe0-9944e81ba661/multi symptom cold.jpg)
| NDC | 0498-1070-01, 0498-1070-10, 0498-1070-25, 0498-1070-50, 0498-1170-01, 0498-1170-10, 0498-1170-50 |
| Set ID | 9771b30a-15bc-420a-abe0-9944e81ba661 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Honeywell Safety Products USA, Inc |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART343 |
- Active Ingredients (in each tablet)
- Purpose
- Uses
-
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg acetaminophen in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen (prescription or nonprescription).
- 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 skin reaction occurs, stop use and seek medical help.
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.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate
- persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
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
- new symptoms occur
- redness or swelling i present
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
- MultiSymptom Cold
- Multi Symptom Cold
-
INGREDIENTS AND APPEARANCE
MULTI SYMPTOM COLD
acetaminophen, dextromethorphan, phenylephrine, guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-1170 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 162 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color orange (BRIGHT ORANGE) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-1170-50 500 in 1 CARTON 01/02/2017 1 NDC:0498-1170-01 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0498-1170-10 100 in 1 BOX 01/02/2017 2 NDC:0498-1170-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/02/2017 MULTI SYMPTOM COLD
acetaminophen, dextromethorphan, phenylephrine, guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-1070 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 162 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color orange (BRIGHT ORANGE) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-1070-50 250 in 1 CARTON 04/24/2012 01/01/2017 1 NDC:0498-1070-25 125 in 1 CARTON 1 NDC:0498-1070-10 50 in 1 CARTON 1 NDC:0498-1070-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/24/2012 01/01/2017 Labeler - Honeywell Safety Products USA, Inc (079287321) Registrant - Honeywell Safety Products USA, Inc (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc 079287321 repack(0498-1070, 0498-1170)
