![7 SELECT NIGHT TIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [7-ELEVEN]](https://medic.hrt.org//dailymed/images/e0ef4b9b-6ae4-42c8-ad56-6ed64114e9f9/image-01.jpg)
| NDC | 10202-335-40 |
| Set ID | e0ef4b9b-6ae4-42c8-ad56-6ed64114e9f9 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | 7-Eleven |
| Generic Name | |
| Product Class | Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 30 mL)
- Purpose
- Uses
temporarily relieves common cold/flu symptoms:
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- cough due to minor throat and bronchial irritation
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- sore throat
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- headache
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- minor aches and pains
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- fever
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- runny nose and sneezing
- Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
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- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- excitability may occur, especially in children
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
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- pain or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
CloseKeep 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.
- Directions
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- take only as directed – see Overdose warning
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- use dose cup
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- do not exceed 4 doses per 24 hrs
Closeadults & children 12 yrs & over
30 mL every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
- Other information
- Inactive ingredients
alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Close - Questions or comments?
- Package/Label Principal Display Panel
Compare to Vicks® NyQuil® Cold & Flu active ingredients
Powerful Nighttime Relief
Night Time Relief
Acetaminophen
Dextromethorphan HBr
Doxylamine Succinate
Cold & Flu Relief
Pain Reliever – Fever Reducer
Cough Suppressant – Antihistamine
ALCOHOL 10%
12 FL OZ (354 mL)
Close - INGREDIENTS AND APPEARANCE
7 SELECT NIGHT TIME RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-335 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color GREEN (clear, bright green) Score Shape Size Flavor FRUIT (anise / cooling menthol aroma) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10202-335-40 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/05/2014 CloseLabeler - 7-Eleven (007347602)
