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

Sanatos Nighttime Multi Symptoms by

Drug Labeling and Warnings

Sanatos Nighttime Multi Symptoms 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 dose cup): Purposes
• Acetaminophen 650 mg: Pain reliever/fever reducer
• Dextromethorphan HBr 30 mg: Cough suppressant
• Doxylamine succinate 12 mg: Antihistamine

Uses

temporarily relieves these common cold/flu symptoms:

• sore throat
• headache
• minor aches and pains
• fever

• runny nose and sneezing
• cough due to minor throat and bronchial irritation

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

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.

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

• each 30 mL dose cup contains: sodium 45 mg
• store at room temperature

Tamper Evident: Do not use if imprinted shrink band is missing or broken.

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?

call 1-866-359-3478

Distributed by:

Pharmadel LLC

Seaford, DE 19973

www.sanatos.com

Princpal Display Panel

Alcohol- Free / Original Flavor

SanaTos®

Nighttime

MULTI-SYMPTOMS COLD

& FLU RELIEF

Acetaminophen,

Dextromethorphan HBr, Doxylamine Succinate

• Minor Aches & Pains, Fever
• Sore Throat
• Sneezing, Runny Nose
• Cough

NEW & IMPROVED

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

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

Product 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)