CONRX NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate tablet

ConRx NightTime by

Drug Labeling and Warnings

ConRx NightTime by is a Otc medication manufactured, distributed, or labeled by Eagle Distributors,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each Caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 15 mg	Cough suppressant
Dexylamine 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
• fever
• runny nose and 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 every day 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 wheather a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking 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 sleep

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 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
• 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, and 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

Taking more than directed can cause serious health problems. 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 - see Overdose warning
• do no exceed 4 doses per 24 hours

adult and children 12 years and over, 2 Caplets with water every 6 hours
children 4 to under 12 years, ask a doctor
children under 4 years, do not use

Other information

• store at room temperature

Inactive ingredients

cross carmellose sodium, D&C Yellow No.10, FD&C Blue No.1, cellulose microcrystalline, polysorbate 80, silicone dioxide, talc, titanium dioxide, corn starch, gelatin, magnesium stearate, sodium starch glycolate, sodium benzoate, hydroxy propyl methyl

Questions?

1-855-619-7900

PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box

Compare to the Active Ingredients in
NyQuil®

ConRx® NightTime
COLD & FLU
NightTime Relief

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

• ⋆ Aches, Fever & Sore Throat
• ⋆ Sneezing, Runny Nose
• ⋆ Cough

2 Caplets Each Pouch

TO OPEN
PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in
NyQuil®

2 Caplets Each Pouch

INGREDIENTS AND APPEARANCE

CONRX NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68737-239
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	OVAL	Size	18mm
Flavor		Imprint Code	CRX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68737-239-23	50 in 1 BOX
1		2 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/10/2014

Labeler - Eagle Distributors,Inc. (929837425)