NDC | 55758-023-06 |
Set ID | 6052e596-3f4f-043b-e053-2a91aa0a053f |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmadel LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Active Ingredients & Purposes
- Uses
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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 everyday 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.
- to make a child sleepy
Ask a doctor before use if you have
- a sodium-restricted diet
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by fever
- fever gets worse or lasts more than 3 days
- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts
These could be signs of a serious condition.
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Directions
- take only as recommended - see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
age dose adults & children 12 years & over 30 mL(2TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use - If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.
- Other informaiton
- Inactive ingredients
- Questions?
- Distributed by:
- Princpal Display Panel
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INGREDIENTS AND APPEARANCE
SANATOS NIGHTTIME MULTI SYMPTOMS
acetaminophen, dextromethorphan hbr, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-023 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color green Score Shape Size Flavor ANISE (Medicinal) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-023-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/01/2014 Labeler - Pharmadel LLC (030129680)