NDC | 10202-994-73 |
Set ID | e61aee43-63c4-43b4-9ac8-c99a50726103 |
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 softgel)
- Purpose
- Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- cough due to minor throat and bronchial irritation
- •
- sore throat
- •
- headache
- •
- minor aches and pains
- •
- fever
- 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
- •
- heart disease
- •
- thyroid disease
- •
- diabetes
- •
- high blood pressure
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion 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.
- 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 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
- Inactive ingredients
edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Close - Questions or comments?
- Principal Display Panel
Compare to DayQuil® LiquiCaps® active ingredients
QUALITY GUARANTEED
Non-Drowsy
Day Time Relief
Acetaminophen
Dextromethorphan HBr
Phenylephrine HCl
Cold & Flu Relief
Pain Reliever • Fever Reducer
Cough Suppressant • Nasal Decongestant
Alcohol Free/Antihistamine Free
16 SOFTGELS
Actual Size
Close - INGREDIENTS AND APPEARANCE
7 SELECT DAY TIME RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-994 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 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) POVIDONES (UNII: FZ989GH94E) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor Imprint Code L994 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10202-994-73 8 in 1 CARTON 04/22/2014 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 04/22/2014 Labeler - 7-Eleven (007347602)