CONRX DAYTIME- phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide, and guaifenesin tablet

ConRX DayTime by

Drug Labeling and Warnings

ConRX DayTime 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 Caple	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestan

Uses

temporarily relieves common cold/flu symptoms:

• nasal congestion
• sinus congestion & pressure
• cough due to minor
• throat & bronchial irritation
• minor aches & pains
• headache
• fever
• sore throat
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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.

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product

• do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion, 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 4 hours
  •   children 4 to under 12 years, ask a doctor
  •   children under 4 years, do not use

Other information

• each caplet contains: sodium 4 mg
• store at room temperature

Inactive ingredients

sodium starch glycolate, croscarmellose sodium, FD&C Yellow No. 6, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidones, corn starch, gelatin, magnesium stearate, silicon dioxide, stearic acid, talc, titanium dioxide, sodium benzoate hydroxypropylmethyl cellulose

Questions?

1-855-619-7900

PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box

Compare to the Active Ingredients in
DayQuil®
SEVERE

ConRx®

DayTime
COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

MAX
STRENGTH

Non-Drowsy

• Headache, Fever, Sore Throat, Minor Aches & Pains
• Nasal/Sinus Congestion & Sinus Pressure
• Cough
• Chest Congestion

2 Caplets Each Pouch

TO OPEN
PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in
DayQuil®
SEVERE

2 Caplets Each Pouch

INGREDIENTS AND APPEARANCE

CONRX DAYTIME 
phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide, and guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68737-238
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Maltodextrin (UNII: 7CVR7L4A2D)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Povidones (UNII: FZ989GH94E)
Polyethylene Glycols (UNII: 3WJQ0SDW1A)
Silicon dioxide (UNII: ETJ7Z6XBU4)
Talc (UNII: 7SEV7J4R1U)
Titanium dioxide (UNII: 15FIX9V2JP)
Stearic Acid (UNII: 4ELV7Z65AP)
Polyvinyl Alcohol (UNII: 532B59J990)
Starch, Corn (UNII: O8232NY3SJ)
Gelatin (UNII: 2G86QN327L)
Magnesium Stearate (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
Sodium Benzoate (UNII: OJ245FE5EU)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	ORANGE	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: 68737-238-22	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	01/31/2014

Labeler - Eagle Distributors,Inc (929837425)