![NIGHTTIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC]](https://medic.hrt.org//dailymed/images/155a7168-b568-41f4-b8a2-214889b4eccf/nighttime-cold-and-flu-original-liquid-ric-1.jpg)
| NDC | 49580-0346-2, 49580-0346-4, 49580-0346-8 |
| Set ID | 155a7168-b568-41f4-b8a2-214889b4eccf |
| Category | HUMAN OTC DRUG LABEL |
| Packager | P & L Development, LLC |
| Generic Name | |
| Product Class | Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 30 mL)
- Purposes
- Uses
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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, persists for more than 2 days, is accompanied or is 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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 take more than 4 doses in any 24-hour peroid
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years of age: do not use
- When using other Day Time or Night Time products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions or Comments?
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Principal Display Panel
*Compare to active ingredients in Vicks® NyQuil®* Cold & Flu*
Night Time
Cold & Flu
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
pain reliever/fever reducer
cough suppressant
antihistamine
relieves:
- fever,
- headache
- sore throat
- cough
- minor aches and pains
- runny nose & sneezing
for ages 12 years & over
alcohol 10%
FL OZ (mL)
*This product is not manufactured or distributed by The Procter & Gamble Company, Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
- Product Label
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INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU READYINCASE
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0346 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0346-2 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/30/2014 2 NDC:49580-0346-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/30/2014 3 NDC:49580-0346-8 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 11/30/2014 Labeler - P & L Development, LLC (101896231)
