Meijer Distribution, Inc. Nite Time Cold & Flu Drug Facts

All-Nite Cold and Flu by

Drug Labeling and Warnings

All-Nite Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALL-NITE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Meijer Distribution, Inc. Nite Time Cold & Flu Drug Facts

Active ingredient (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

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

• more than 4 doses (2,600 mg acetaminophen) 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 two 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.
• to make a child sleepy
• 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
• glaucoma
• a sodium-restricted diet
• 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

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• 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
• pain or cough gets worse or lasts more than 7 days
• 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.
• new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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.

Directions

• take only as directed – see Liver warning
• use dose cup
• do not exceed 4 doses per 24 hours

• adults and children 12 years and over:

  30 mL (2 TBSP) every 6 hours

• children under 12 years children under 4 years:

  ask a doctor

  do not use

• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
• each 30 mL dose cup contains: sodium content: 38 mg

Other information

• each 30 mL dose cup contains: sodium 38 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, citric acid, flavor, FD&C greeen no. 3, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, FD&C yellow no. 6, FD&C yellow no. 10

Questions or comments?

1-800-616-2471

Principal Display Panel

Compare to Vicks® NyQuil® Cold & Flu active ingredients

SEE NEW WARNINGS INFORMATION

Original Flaror

All-Nite Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Multi Symptom Relief

Acetaminophen - aches, fever

Dextromethorphan HBr - cough

Doxylamine Succinate - sneezing, runny nose

ALCOHOL 10%

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5777
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
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color	GREEN (Bright)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5777-09	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/18/2009	08/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/18/2009	08/03/2019

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020

Document Id: 4ae4644b-c1da-4c3b-8e39-c54594998b18

34390-5

Set id: dde686d5-fde0-472b-82ac-777061969b2c

Version: 3

Effective Time: 20200103