![7 SELECT NIGHT TIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [7-ELEVEN]](https://medic.hrt.org//dailymed/images/b8a9ec6b-380b-4377-b154-7a99922430ba/056SD-night-time.jpg)
| NDC | 10202-056-73 |
| Set ID | b8a9ec6b-380b-4377-b154-7a99922430ba |
| Category | HUMAN OTC DRUG LABEL |
| Packager | 7-Eleven |
| Generic Name | |
| Product Class | Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
- 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 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using this product
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.
Sore throat warning: If sore throat is severe, lasts 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 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- •
- liver disease
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- •
- trouble urinating due to an 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
- •
- 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
CloseStop 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.
- Keep out of reach of children.
Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Close - Directions
- •
- take only as directed – see overdose warning
- •
- do not exceed 4 doses per 24 hours
Closeadults & 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
- Inactive Ingredients
D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Close - Package/Label Principal Display Panel
Compare to NyQuil® LiquiCaps® active ingredients
QUALITY GUARANTEED
Night Time Relief
Acetaminophen
Dextromethorphan HBr
Doxylamine Succinate
Cold & Flu Relief
Pain Reliever • Fever Reducer
Cough Suppressant • Antihistamine
16 SOFTGELS
Actual Size
Close - INGREDIENTS AND APPEARANCE
7 SELECT NIGHT TIME RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-056 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 GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color GREEN (clear) Score no score Shape OVAL Size 20mm Flavor Imprint Code 056 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10202-056-73 8 in 1 CARTON 04/17/2014 1 2 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 04/17/2014 CloseLabeler - 7-Eleven (007347602)
