![DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]](https://medic.hrt.org//dailymed/images/c018031f-66b4-4fd8-99b7-84839d459fa7/day-time-pe-liquid-1.jpg)
| NDC | 49580-0467-2 |
| Set ID | c018031f-66b4-4fd8-99b7-84839d459fa7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | P & L Development, LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 15 mL)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
Allery 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
- 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occurs
- 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
- 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: 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) 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
- do not take more than directed (see overdose warning)
- do not exceed 4 doses in any 24 hour-period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL=milliliter
adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask 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
- Questions or comments?
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Principal Display Panel
non-drowsy daytime
cold & flu relief
acetaminophen (pain reliever/fever reducer)
dextromethorphan HBr (cough suppressant)
phenylephrine HCl (nasal decongestant)
- for ages 6 years & over
- Alcohol-free
- antihistamine-free
FL OZ (mL)
*Compare to the active ingredients in Vicks® DayQuil® Cold &Flu
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
- Package Label
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0467 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0467-2 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/31/2017 Labeler - P & L Development, LLC (101896231)
