![NITETIME COLD/FLU, MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]](https://medic.hrt.org//dailymed/images/9033bf94-f444-4488-b717-050d04dee388/Carton Back.jpg)
![NITETIME COLD/FLU, MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [WAL-MART STORES INC]](https://medic.hrt.org//dailymed/images/9033bf94-f444-4488-b717-050d04dee388/Carton Front.jpg)
| NDC | 49035-978-04 |
| Set ID | 9033bf94-f444-4488-b717-050d04dee388 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Wal-Mart Stores Inc |
| Generic Name | |
| Product Class | Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredient (in each softgel)
- Purposes
- 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 daily while using this product
Sore throat warning
If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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.
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.
- 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, & 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.
-
Directions
- take only as directed - see Overdose warning
- 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
when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
- Other information
- Inactive ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - Carton Label
-
INGREDIENTS AND APPEARANCE
NITETIME COLD/FLU, MULTI-SYMPTOM RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-978 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color green (clear) Score no score Shape capsule (Oblong) Size 21mm Flavor Imprint Code PC10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-978-04 2 in 1 PACKAGE 03/09/2016 1 12 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 final part341 03/09/2016 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture(49035-978) , analysis(49035-978)
