BASIC CARE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)
Available from:
L. Perrigo Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Antihistamine temporarily relieves common cold/flu symptoms:
Authorization status:
OTC monograph final
Authorization number:
0113-7056-67

BASIC CARE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr,

doxylamine succinate capsule, liquid filled

L. Perrigo Company

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.

----------

Amazon Nighttime Cold & Flu Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Us es

temporarily relieves common cold/flu symptoms:

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed

cough due to minor throat and bronchial irritation

sore throat

headache

minor aches and pains

fever

runny nose and sneezing

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: 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

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

liver disease

glaucoma

cough that occurs with too much phlegm (mucus)

a breathing problem such as emphysema or chronic bronchitis

persistent or chronic cough as occurs with smoking, asthma, or emphysema

trouble urinating due to an enlarged prostate gland

taking sedatives or tranquilizers

taking the blood thinning drug warfarin

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

pain 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.

do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone,

propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Vicks

NyQuil® Cold & Flu active ingredients

Nighttime Relief

nighttime cold & flu

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Alcohol Free

actual size

Multi-Symptom Relief

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose

Cough

48 Softgels

take only as directed – see overdose warning

do not exceed 4 doses per 24 hours

store at 20-25 C (68-77 F)

BASIC CARE NIGHTTIME COLD AND FLU

acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-70 56

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

15 mg

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

6 .25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

GREEN (clear)

S core

no sco re

S hap e

OVAL

S iz e

20 mm

Flavor

Imprint Code

0 56

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-70 56 -6 7

24 in 1 CARTON

0 1/0 9 /20 19

1

2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

L. Perrigo Company

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 1/0 9 /20 19

Labeler -

L. Perrigo Company (006013346)

Revised: 5/2019

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