SANATOS NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Sanatos by

Drug Labeling and Warnings

Sanatos by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients and Purposes

• Active ingredients (in each softgel): Purposes
• Acetaminophen 325 mg ..............:

  Pain reliever/ fever reducer

• Dextromethorphan HBr 15 mg ......: Cough suppressant
• Doxylamine succinate 6.25 mg .....: Antihistamine

Uses

Temporarily relieves common cold/flu symptoms

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes due to hay fever
• and fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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.

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.
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

• liver disease
• glaucoma
• a cough that is accompanied by excessive phlegm (mucus)
• a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to an 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

• excitability may occur, especially in children
• may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase drowsiness effect
• avoid alcoholic drinks
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 5 days
• redness or swelling is present
• new symptoms occur
• cough comes back, occurs with a rash or a persistent headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information

• store between 68-77°F (20-25°C)
• avoid excessive heat
• do not use if blister pack is punctured or torn

Directions

• do not exceed recommended dosage (see Liver warning)
• do not exceed 4 doses in a 24 hour period or as directed by a doctor

• Age: Dose
• adults and children 12 years and older: 2 softgels every 6 hours
• children 4 to under 12 years: consult a doctor
• children under 4 years: do not use

Inactive ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone k-30, propylene glycol, propylparaben, sorbitol, titanium dioxide, water.

Questions or comments?

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Distributed by:

PHARMADEL LLC

New Castle, DE, 19720

/PHARMADELUSA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANATOS  NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-042
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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	SN3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-042-08	1 in 1 CARTON	04/04/2023
1		8 in 1 BLISTER PACK; 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	04/04/2023

Labeler - Pharmadel LLC (030129680)