NITE TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Nite Time Cold and Flu by

Drug Labeling and Warnings

Nite Time Cold and Flu by is a Otc medication manufactured, distributed, or labeled by AAFES/Your Military Exchanges. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves these common cold/flu symptoms:

• minor aches and pains
• headache
• sore throat
• fever
• runny nose and sneezing
• cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses (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

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 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)
• breathing problems or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• trouble urinating due to an 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
• redness or swelling is present
• new symptoms occur
• fever gets worse or lasts more than 3 days
• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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.

Directions

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in any 24-hour period
• 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 ensure correct dosing

Other information

• each 30 mL contains: potassium 5 mg,
• each 30 mL contains: sodium 19 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

*Compare to the active ingredients in Vicks® NyQuil® Cold & Flu

For ages 12 years & over

Nite Time

Cold & Flu

Multi Symptom

Acetaminophen...Aches, fever

Dextromethorphan HBr.....Cough

Doxylamine succinate....Sneezing, Runny Nose

10% Alcohol

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 DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

Manufactured for Your Military Exchanges

By: PL Developments, 11865 S Alameda St

Lynwood, CA 90262

Product Label

EXCHANGE SELECT Nite Time Cold & Flu

INGREDIENTS AND APPEARANCE

NITE TIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-344
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
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: 55301-344-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/31/2016

Labeler - AAFES/Your Military Exchanges (001695568)