![NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)]](https://medic.hrt.org//dailymed/images/07e8021f-a20b-4ce6-828d-5bcb84df4850/night-time-cold-and-flu-original-liquid-delisted-1.jpg)
| NDC | 53441-344-08 |
| Set ID | 07e8021f-a20b-4ce6-828d-5bcb84df4850 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | National Distribution Network (Smart Choice) |
| Generic Name | |
| Product Class | Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 30 mL, 2 tablespoons)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses ( 8 tablespoons or 120 mL) in 24 hours, which is the maximum daily amount
- 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- to make a child sleepy
- 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 you have
- liver disease
- glaucoma
- breathing problems
- chronic bronchitis
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- do not use more than directed (see overdose warning)
- 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
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 7 days
- 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
- take only as recommended (see overdose warning)
- do not exceed 4 doses per 24 hours
- use dosing cup provided
- tbsp=tablespoon, mL= milliliter
age dose adults & children 12 years & over 2 tablespoons (30 mL) every 6 hours children 4 to 11 years do not use unless directed by a doctor children under 4 years 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 the active ingredients in Vicks® NyQuil®*
Night Time
Cold & Flu
Acetaminophen
- Pain Reliever/Fever Reducer
Dextromethorphan HBr
- Cough Suppressant
Doxylamine succinate
- Antihistamine
- Aches, fever, cough, runny nose and sneezing
- for ages 12 and over
- alcohol 10%
FL OZ (mL)
Original Flavor
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
Failure to follow these warnings could result in serious consequences.
DISTRIBUTED BY
NATIONAL DISTRIBUTION NETWORK
P.O. BOX 875
MELVILLE, NY 11747-0875
- Product Label
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INGREDIENTS AND APPEARANCE
NIGHT TIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53441-344 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53441-344-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2014 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/31/2014 12/30/2021 Labeler - National Distribution Network (Smart Choice) (045099210)
