Label: SANATOS MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tablet
- NDC Code(s): 55758-361-02, 55758-361-99
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 20, 2022
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Warnings
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert:
Acetaminophen may cause severe skine 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 vomitting, consult a doctor promptly.
Do not use
- with any 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, asl a doctor or pharmacist before taking this product.
- for more than 7 days for pain and 3 days or fever, unless directed by a doctor.
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INGREDIENTS AND APPEARANCE
SANATOS MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-361 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) TALC (UNII: 7SEV7J4R1U) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) Product Characteristics Color white Score score with uneven pieces Shape OVAL Size 17mm Flavor Imprint Code A12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-361-02 2 in 1 PACKET; Type 0: Not a Combination Product 08/01/2020 2 NDC:55758-361-99 50 in 1 CARTON 08/01/2020 2 NDC:55758-361-02 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 Drug M012 08/01/2020 Labeler - Pharmadel LLC (030129680)