SANATOS MULTI SYMPTOMS NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

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 & Purposes

• Active ingredients (in each 30 mL): Purposes
• Acetaminophen 650 mg: Pain reliever/ fever reducer
• Dextromethorphan HBr 30 mg: Cough suppressant
• Doxylamine succinate 12.5 mg: Antihistamine

Uses

Temporarily relieves common cold/flu symptoms associated with

• minor aches and pains
• headache
• sore throat
• runny nose
• cough due to minor throat and bronchial irritation
• sneezing
• temoprarily reduces fever

Warnings

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

• adults take more than 4 doses in 24 hours, which is the maxium daily amount
• child takes more than 3 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday 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.

Ask a doctor before use if user

• has a sodium-restricted diet
• has liver disease
• has glaucoma
• has cough that occurs with too much phlegm (mucus)
• has a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• has trouble urinating due to enlarged prostate gland
• is a child with pain of arthritis

Ask a doctor or pharmacist before use if user is

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• avoid alcoholic beverages
• 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 (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• any new symptoms occur
• cough comes back, or occurs with rash or 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• use only dosing cup provided
• shake well before use
• if you are taking other cold/flu products, read complete labeling

• adults & children 12 years & over: 30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours
• children under 12 years: ask a doctor

Other informaiton

• each 30 mL contains: sodium 10 mg
• store between 68-77°F (20-25°C)

Inactive ingredients

citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

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

Distributed by:

Pharmadel

New Castle, DE 19720

www.pharmadel.com

Facebook/PHARMADELUSA

Princpal Display Panel

INGREDIENTS AND APPEARANCE

SANATOS  MULTI SYMPTOMS NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-416
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)

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: 55758-416-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/01/2023

Labeler - Pharmadel LLC (030129680)