NEXT DAY TIME NON DROWSY COLD AND FLUE- acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hci 5 mg capsule, liquid filled

Next Day Time by

Drug Labeling and Warnings

Next Day Time by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets 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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other products 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 drugs. 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 trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur pain, nasal congestion 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.

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)
Adults and children 12 years and over: ■ take 2 caplets every 4 hours ■ do not take more than a total of 12 caplets in 24 hours
Children under 12 years:Do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

store between 15-30°C (59-86°F) do not use if blister is torn or open

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicone dioxide, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-877-99-GENOM (43666)

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

NEXT DAY TIME  NON DROWSY COLD AND FLUE
acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hci 5 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-356
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-356-09	10 in 1 BOX; Type 0: Not a Combination Product	01/19/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/19/2015

Labeler - Genomma Lab USA (832323534)

Registrant - Genomma Lab USA (832323534)