NIGHTTIME COLD AND FLU RELIEF PLUS- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule

Nighttime Cold and Flu Relief Plus by

Drug Labeling and Warnings

Nighttime Cold and Flu Relief Plus by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium,LLC, Accucaps Industries Limited, Legacy Pharmaceutical Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each capsule)

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant  

Uses

• temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • nasal and sinus congestion
  • runny nose
  • headache
  • cough
  • sneezing
  • sore throat

• temporarily reduces fever

Warnings

Liver warnings: This product contains acetaminophen.
Sever liver damage may occur if you take

• more than 10 capsules in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock

If a skin or general allergic 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 to sedate children.

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
• in children under 12 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough with excessive phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not exceed recommended dosage
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• pain, cough, or nasal congestion 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.
• nervousness, dizziness, or sleeplessness occurs

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. 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 the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Other information

• store at controlled room temperature 15°C to 30°C (59°F to 86°F)
• do not use if blister seal is ripped or broken

INACTIVE INGREDIENT

Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerine, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

QUESTIONS

Questions or comments? 1-800-706-5575

*This product is not manufactured or distributed by Bayer HealthCare LLc., distributor of Alka- Seltzer PLUS® Night Multi-Symptom Cold & Flu Formula.

Principal Display Panel

Premier Value
NIGHTTIME Cold & Flu Relief Plus
NDC number 68016-720-20
20 Liquid Capsule

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-720
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	42A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-720-20	2 in 1 BLISTER PACK
1		10 in 1 CARTON; 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	09/23/2015

Labeler - Chain Drug Consortium,LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	analysis(68016-720) , manufacture(68016-720)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		243944050	analysis(68016-720) , manufacture(68016-720)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging		969852743	pack(68016-720)