NYQUIL SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, coated

NyQuil Severe Cold and Flu by

Drug Labeling and Warnings

NyQuil Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Savings Distributors LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCL 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation

cough to help you sleep minor aches & pains headache

fever sore throat runny nose & sneezing

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

Warnings

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

more than 8 caplets 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 reactions. Symptoms may include: Skin reddening Blisters Rash

If a skin reaction occurs, stop ues 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.

Ask a doctor before use if you have

liver disease heart disease high blood pressure thyroid disease

diabetes glaucoma cough that occurs with too much phlegm (mucus)

a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before ues if you are

taking sedatives or tranquilizers taking the blood thinning drug warfarin

When using this product

do not use more than directed

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

you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 7 days

fever gets wore 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.

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

take only as directed do not exceed 8 caplets per 24 hrs

adults & children 12 yrs & over 2 caplets with water every 4 hrs

children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other Information

do not exceed 25ºC

Inactive ingredients

crospovidone, D&C Yellow No.10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake,FD&C Yellow No.6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

1-800-362-1683

Package Label

INGREDIENTS AND APPEARANCE

NYQUIL SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73097-009(NDC:37000-813)
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CROSPOVIDONE (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	1mm
Flavor		Imprint Code	NQ
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73097-009-25	50 in 1 CARTON	07/08/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73097-009-02	1 in 1 CARTON	07/08/2019
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 73097-009-20	40 in 1 CARTON	07/08/2019
3		2 in 1 POUCH; 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	07/08/2019

Labeler - Savings Distributors LLC (010527359)