![DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [SAFEWAY, INC.]](https://medic.hrt.org//dailymed/images/6cb77b28-1ff0-445a-966e-07c6726ce0ff/non-drowsy-daytime-cold-and-flu-relief-delisted-1.jpg)
| NDC | 21130-311-12 |
| Set ID | 6cb77b28-1ff0-445a-966e-07c6726ce0ff |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Safeway, Inc. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours for adults
- more than 5 doses (5 tablespoons or 75 mL) in 24 hours for children 6-12 years old
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
- 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.
- 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 allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if the user has
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- a sodium-restricted diet
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to enlarged prostate gland
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness or sleeplessness occur
- fever gets worse or lasts more than 3 days
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 91-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- take only as recommended (see overdose warning)
- do not exceed 5 doses(children) or 6 doses (adults per 24 hours
- measure only with dosing cup provided
- keep dosing cup with product
- tbsp=tablespoon, mL= milliliter
age dose adults and children 12 years and over 2 tbsp (30 mL) every 4 hours children 6 to 11 years 1 tbsp (15 mL) every 4 hours children 4 to 5 years do not use unless directed by a doctor children under 4 years do not use - When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
- Other information
- Inactive ingredients
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Principal Display Panel
Non-Drowsy
Daytime
Cold & Flu Relief
Acetaminophen 325 mg-Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg-COugh Suppressant
Phenylephrine HCl 5 mg- Nasal Decongestant
Original Flavor
Compare to Vicks® DayQuil® active ingredients*
- Alcohol free
- Antihistamine free
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil®
Failure to follow these warnings could result in serious consequences.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-SAFEWAY
- Product Label
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU RELIEF NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-311 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-311-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2014 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/30/2014 12/30/2021 Labeler - Safeway, Inc. (009137209)
