![7 SELECT DAY TIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [7-ELEVEN]](https://medic.hrt.org//dailymed/images/abcd8682-a8ce-424c-9b72-65f5ada5c48a/7-1-16 65640SDF3 only image.jpg)
| NDC | 10202-656-40 |
| Set ID | abcd8682-a8ce-424c-9b72-65f5ada5c48a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | 7-Eleven |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 15 mL)
- Purpose
- Uses
- •
- temporarily relieves common cold/flu symptoms:
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- nasal congestion
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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
- Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- •
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- •
- child takes more than 5 doses in 24 hours
- •
- taken with other drugs containing acetaminophen
- •
- adult has 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, 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 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
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- liver disease
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- heart disease
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- high blood pressure
- •
- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
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- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- •
- 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
- •
- 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
- •
- take only as directed – see Overdose warning
- •
- only use the dose cup provided
- •
- do not exceed 4 doses per 24 hrs
Closeadults & children 12 yrs & over
30 mL every 4 hrs
children 6 to under 12 yrs
15 mL every 4 hrs
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use
- Other information
- Inactive ingredients
butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Close - Questions or comments?
- Principal Display Panel
Compare to Vicks® DayQuil® Cold & Flu active ingredients
Powerful Non-Drowsy Relief
See New Warnings
Day Time Relief
Acetaminophen
Phenylephrine HCl
Dextromethorphan HBr
Cold & Flu Relief
Pain Reliever – Fever Reducer
Cough Suppressant – Nasal Decongestant
Alcohol Free/Antihistamine Free
12 FL OZ (354 mL)
Close - INGREDIENTS AND APPEARANCE
7 SELECT DAY TIME RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-656 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Product Characteristics Color ORANGE (clear) Score Shape Size Flavor MENTHOL (with fruit) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10202-656-40 354 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)
