NITECIN- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Nitecin by

Drug Labeling and Warnings

Nitecin by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each Softgels)	Purpose
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 & bronchial irritation
• Sore throat
• Headache
• Minor aches & pains
• Fever
• Runny nose & sneezing

Warnings

Liver warning

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

• more than 4 doses in 24 hrs, 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

Sore throat warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 you have

• 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 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
• Marked drowsiness may occur
• Avoid Alcoholic drinks
• Be careful when driving a motor vehicle or operating machinery
• Alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

• Pain or cough gets worse or lasts more than 7 days
• Fever gets worse or lasts more than 3 days
• Redness or swelling is present
• 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.

Overdose warning

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

Directions

• Take only as directed
• Do not exceed 4 doses per 24 hrs

• Adults & children 12 yrs & over: 2 softgels with water every 6 hrs
• Children 4 to under 12 yrs: Ask a doctor
• Children under 4 yrs: Do not use

Other information

• Store at room temperature

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST

SPL UNCLASSIFIED SECTION

Made for:

RRX

Exclusively distributed by:

OPMX
Chula Vista, CA 91910

PRINCIPAL DISPLAY PANEL

NDC: 69729-054-10

Cough & Flu/ Tos y Gripe

Nitecin

Night-ttmeRelief

Multi-Symptom Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

• Headache/ Dolor de cabeza
• Fever/ Fiebre
• Sore Throat/ Dolor de Garganta
• Sneezing/ Estornudos
• Runny Nose/ Secreción Nasal
• Cough/ Tos

10 Softgels/ 10 Cápsulas Blandas de Gel

INGREDIENTS AND APPEARANCE

NITECIN 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-054
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	AP02
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-054-10	1 in 1 CARTON	05/23/2022
1		10 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	05/23/2022

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTECH PHARMA PRIVATE LIMITED		677111277	label(69729-054) , manufacture(69729-054) , pack(69729-054)