![DAY TIME COLD AND FLU NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MARC GLASSMAN, INC.]](https://medic.hrt.org//dailymed/images/0e996d7d-29a3-4c13-abe2-99264957b580/daytime-cold-and-flu-liquid-delisted-1.jpg)
| NDC | 68998-311-12 |
| Set ID | 0e996d7d-29a3-4c13-abe2-99264957b580 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Marc Glassman, Inc. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 15 mL, 1 tablespoon)
- 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 everyday 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 non-prescription). 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 an enlarged prostate gland
When using this product,
- avoid alcoholic drinks
- do not use more than directed (see overdose warning)
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness or sleeplessness occurs
- 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 (1-800-222-1222) immediately. 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
- use dosage cup provided
- tbsp=tablespoon, mL=milliliter
age dose adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours children 6 to 11 years 1 tablespoon (15 mL) every 4 hours children 4 to 5 years do not use unless directed by a doctor children under 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
*Compare to active ingredients in Vicks® DayQuil®
non-drowsy
Day Time
Cold & Flu
Acetaminophen- Pain reliever/fever reducer
Dextromethorphan HBr- Cough suppressant
Phenylephrine HCl- Nasal Decongestant
- For Ages 6 & Over
- Alcohol Free
- Antihistamine free
FL OZ (mL)
Failure to follow these warnings could result in serious consequences.
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks®DayQuil®.
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON OR UNDER THE BOTTLE IS BROKEN OR MISSING.
Distributed by:
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130
- Product Label
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INGREDIENTS AND APPEARANCE
DAY TIME COLD AND FLU NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-311 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, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SUCROSE (UNII: C151H8M554) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68998-311-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2014 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/31/2014 12/30/2021 Labeler - Marc Glassman, Inc. (094487477)
