NDC | 68737-239-23 |
Set ID | 8cb2332e-8cc2-405f-9992-eaf068415b19 |
Category | HUMAN OTC DRUG LABEL |
Packager | Eagle Distributors,Inc. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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
-
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
- Inactive ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box
Compare to the Active Ingredients in
NyQuil®ConRx® NightTime
COLD & FLU
NightTime ReliefAcetaminophen, Doxylamine Succinate, Dextromethorphan HBr
- ⋆
- Aches, Fever & Sore Throat
- ⋆
- Sneezing, Runny Nose
- ⋆
- Cough
2 Caplets Each Pouch
TO OPEN
PUSH IN TAB AND PULL OUTCompare to the Active Ingredients in
NyQuil®2 Caplets Each Pouch
-
INGREDIENTS AND APPEARANCE
CONRX NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate tabletProduct 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)