Label: SUNMARK NITE TIME- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate solution
- NDC Code(s): 49348-061-36, 49348-061-37, 49348-061-39, 49348-061-49
- Packager: Mckesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mgClose
Pain reliever/fever reducer
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- minor aches and pains
- runny nose and sneezing
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
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
- 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 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking 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
- 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- take only as directed – see Overdose warning
- use dose cup
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over
30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
- Other Information
- each 30 mL dose cup contains: sodium 38 mg
- store at 20- 25°C (68- 77°F )
- Inactive ingredients
alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrateClose
- Questions or comments?
- Package/Label Principal Display Panel
COMPARE TO VICKS® NYQUIL® COLD & FLU ACTIVE INGREDIENTS
See New Warnings
Cold & Flu
Pain Reliever/Fever Reducer
8 FL OZ (237 mL)Close
- INGREDIENTS AND APPEARANCE
SUNMARK NITE TIME
acetaminophen, dextromethorphan hbr, doxylamine succinate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-061 Route of Administration ORAL DEA Schedule 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 ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color GREEN (clear, bright green) Score Shape Size Flavor FRUIT (anise / cooling menthol aroma) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-061-36 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49348-061-49 295 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49348-061-39 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:49348-061-37 237 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/21/2011 Labeler - Mckesson (177667227)