SANATOS LOZENGES- menthol lozenge

Sanatos Lozenges by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient & Purposes

• Active ingredients (in each lozenge): Purposes
• Menthol 5.5 mg................................................: Cough suppressant / oral anesthetic

Uses

For the temporary relief of

• minor irritation and sore throats
• cough as may occur with a cold

Warnings

Sore throat warning: if sore throat is severe persists for more than 2 days, is accompanied or followed by high fever, headache, rash, nausea or vomiting, consult a doctor promptly. These may be serious.

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• a cough that is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of the reach of children.

Directions

• adult and children 3 to under 12 years of age: allow the lozenge to dissolve one (1) drop slowly in mouth
• repeat every 2 hours as needed or as directed by doctor
• children under 3 years of age: consult a doctor

Other information

• store in cool dry place below 77º F
• protect from heat and light
• do not use if package is torn or broken

Inactive ingredients

ascorbic acid, citric acid monohydrate, cordia dichotoma fruit, corn syrup, eucalyptus oil, hyssopus officinalis flowering top, greater galangal, justicia adhatoda leaf, licorice, long pepper, natural honey flavor, natural lemon flavor, sucrose.

Questions & comments?

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

Principal Display Panel

SanaTos®

Sore Throat Lozenges/Pastillas para el dolor de garganta

Relieves Cough/Alivia la Tos

Soothes Sore Throats/Calma Dolor de Garganta

Honey Lemon Flavor/Sabor Miel y Limón

5 pouches x 25 Lozenges each/5 bolsas x 25 pastillas cada una

INGREDIENTS AND APPEARANCE

SANATOS LOZENGES 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.5 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
JUSTICIA ADHATODA LEAF (UNII: HH159XOV81)
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CORN SYRUP (UNII: 9G5L16BK6N)
GREATER GALANGAL (UNII: 7Y64R856MB)
SUCROSE (UNII: C151H8M554)
LONG PEPPER (UNII: 2NMG4EA7B1)
CORDIA DICHOTOMA FRUIT (UNII: R4RI8646ZR)
LICORICE (UNII: 61ZBX54883)
HONEY (UNII: Y9H1V576FH)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	17mm
Flavor	LEMON, HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-301-05	5 in 1 CARTON	03/28/2019
1	NDC: 55758-301-25	1 in 1 BAG; Type 0: Not a Combination Product
2	NDC: 55758-301-25	1 in 1 BAG; Type 0: Not a Combination Product	03/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/28/2019

Labeler - Pharmadel LLC (030129680)