![7 SELECT NIGHT TIME SEVERE COLD COUGH AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [7-ELEVEN]](https://medic.hrt.org//dailymed/images/f578b10c-ac83-4c51-9d4f-5d7c93f97ca8/96491SDC3.jpg)
| NDC | 10202-964-91 |
| Set ID | f578b10c-ac83-4c51-9d4f-5d7c93f97ca8 |
| 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 packet)
- Purposes
- Uses
- •
- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
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- minor sore throat pain
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- headache
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- nasal and sinus congestion
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- runny nose
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- sneezing
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- itchy nose or throat
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- itchy, watery eyes due to hay fever
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- cough due to minor throat and bronchial irritation
- •
- temporarily reduces fever
- 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
- •
- 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
- •
- in a child under 12 years of age
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- if you have ever had an allergic reaction to this product or any of its ingredients
- •
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- 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.
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
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- thyroid disease
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- diabetes
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
- •
- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
- •
- do not exceed recommended dosage
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- avoid alcoholic drinks
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- marked drowsiness may occur
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
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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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- pain, cough or nasal congestion gets worse or lasts more than 7 days
- •
- 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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- •
- do not use more than directed (see overdose warning)
- •
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
Age
Dose
adults and children 12 years of age and over
one packet
children under 12 years of age
do not use
- •
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- •
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
- Other information
- •
- each packet contains: potassium 10 mg and sodium 25 mg
- •
- phenylketonurics: contains phenylalanine 13 mg per packet
- •
- store at 20-25 °C (68-77 °F). Protect product from heat and moisture.
- Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate
Close - Questions or comments?
- Package/Label Principal Display Panel
Compare to Theraflu® Severe Cold & Cough active ingredients
Night Time Severe Cold, Cough & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine/Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
Alcohol-free
Nasal Congestion
Cough/Runny Nose/Sneezing
Body Ache/Headache/Fever
Sore Throat Pain
Honey Lemon
Infused with White Tea Flavors
6 Packets
Close - INGREDIENTS AND APPEARANCE
7 SELECT NIGHT TIME SEVERE COLD COUGH AND FLU
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-964 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color WHITE (mixture of white, light yellow-orange particles) , ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10202-964-91 6 in 1 CARTON; Type 0: Not a Combination Product 01/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/25/2016 CloseLabeler - 7-Eleven (007347602)
