BASIC CARE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled 
Amazon.com Services LLC

----------

Amazon Nighttime Cold & Flu Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

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

•
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

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

•
skin reddening
•
blisters
•
rash

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 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.
•
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
•
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

Ask a doctor or pharmacist before use if you are

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

When using this product

•
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

•
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.

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 do not notice any signs or symptoms.

Directions

•
take only as directed – see overdose warning
•
do not exceed 4 doses per 24 hours

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

•
store at 20-25°C (68-77°F)

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

Multi-Symptom Relief

Compare to Vicks® NyQuil® Cold & Flu active ingredients

Nighttime Cold & Flu

Acetaminophen, Dextromethorphan HBr

Doxylamine Succinate

Pain Reliever/Fever Reducer, Antihistamine

Cough Suppressant

Alcohol Free

actual size

48 SOFTGELS

nighttime cold and flu image 1
nighttime cold and flu image 2
BASIC CARE NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorGREEN (clear) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code 056
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-056-6724 in 1 CARTON12/28/2020
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:72288-056-6212 in 1 CARTON09/07/2021
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/28/2020
Labeler - Amazon.com Services LLC (128990418)

Revised: 10/2024
Document Id: 1b7bcede-dcd0-4d11-9281-3f8aadd040df
Set id: f4497e56-c69d-4ae9-bd81-80bf2ee1b17f
Version: 3
Effective Time: 20241015
 
Amazon.com Services LLC