CONRX NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate tablet 
Eagle Distributors,Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ConRx® NightTime

Drug Facts

Active ingredients (in each Caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Dexylamine succinate 6.25 mgAntihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

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

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

Principal Display Panel - 50 x 2 Caplet Pouch Box
CONRX NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-239
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg
Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore2 pieces
ShapeOVALSize18mm
FlavorImprint Code CRX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68737-239-2350 in 1 BOX
12 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/10/2014
Labeler - Eagle Distributors,Inc. (929837425)

Revised: 2/2014
Document Id: 490fee50-f524-48dc-ad57-8bfa983f9e46
Set id: 8cb2332e-8cc2-405f-9992-eaf068415b19
Version: 1
Effective Time: 20140211
 
Eagle Distributors,Inc.