Label: SANATOS SEVERE COLD RELIEF NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solution
- NDC Code(s): 55758-385-06
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 27, 2024
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- 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 6 doses 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
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.
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you
- have liver disease
- have heart disease
- have high blood pressure
- have thyroid disease
- have diabetes
- have glaucoma
- have a breathing problem such as emphysema
- have difficulty urinating due to an enlarged prostate gland
- have a breathing problem such as emphysema or chronic bronchitis
- are taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- may cause excitability, especially in children
- use caution when driving a motor vehicle or operating machinery
- may cause marked drowsiness
Stop use and ask doctor if
- nervousness, dizziness, or sleeplessness occur
- redness or swelling is present
- pain, cough, or nasal congestion persists or gets worse or last more than 7 days
- fever gets worse or lasts more than 3 days
- any new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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Directions
- dissolve one packet in an 8oz. glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
- sip while hot and consume the entire drink within 10-15 minutes
- adults & children 12 years of age and over: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
SANATOS SEVERE COLD RELIEF NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-385 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color Score Shape Size Flavor HONEY, LEMON (Eucalyptus Honey Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-385-06 6 in 1 CARTON; Type 0: Not a Combination Product 03/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/31/2024 Labeler - Pharmadel LLC (030129680)
