Cough and Sore Throat Daytime

Manufacturer: Kinray LLC
Effective date: 2014-05-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:09

Label at a glance#

ProductCough and Sore Throat Daytime

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE

Label structure9 sections

Indications and uses

sore throat headache minor aches and pains cough due to a cold temporarily relieves fever

Dosage and administration

Take only as recommended - see overdose warning use dose cup or Tabelspoon (TBSP) every 6 hours as needed do not exceed 4 doses in 24-hour period Adults and children 12 years of age and over take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed Children under 12 years do not use this product in children under 12 years of age: this will provide more than the recommended dose (overdose) and ma...

Storage and handling

Store at room temperature 15°- 30°C (59° - 86°F) Protect from freezing each tablespoon contains: sodium 21 mg TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Contacts and useful links#

PhoneLabel contact1-845-692-5799

Label contents#

Full prescribing information#

Active ingredients (in each 15 mL tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever / Fever reducer

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

sore throat
headache
minor aches and pains
cough due to a cold
temporarily relieves fever

Warnings

WARNINGS SECTION

Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Acetaminophen or oter pain releivers/ fever reducers.

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

more than 4 doses in 24 hours, which is the maximum daily amount of this product
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

OTC - DO NOT USE SECTION

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.
to make a child sleep
if you are allergic to acetaminophen or any of the ingredients in this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product do not use more than directed

OTC - WHEN USING SECTION

excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

overdose warning: taking more than recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Take only as recommended - see overdose warning
use dose cup or Tabelspoon (TBSP) every 6 hours as needed
do not exceed 4 doses in 24-hour period

Adults and

children 12 years of age

and over

take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed

Children under 12 years

do not use this product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°- 30°C (59° - 86°F)
Protect from freezing
each tablespoon contains: sodium 21 mg

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxy methyl cellulose sodium, citric acid, FD&C Blue #1, flavor, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol and sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-845-692-5799

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1359455	Acetaminophen/Dextromethorphan (Oral Liquid)	acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61715-076-08	2025-06-02	C162847	48780-1	9855e2a2-4c8c-60a7-e053-dbdaa90a05bd	Cough and Sore Throat Drug Facts
61715-076-08	2019-11-27	C162847	48780-1	9855e2a2-4c8c-60a7-e053-dbdaa90a05bd	Cough and Sore Throat Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61715-076	COUGH AND SORE THROAT DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) LIQUID [KINRAY LLC]	1	Legacy NDC	20140527_ba17b25c-fc4d-4673-82a3-49ab07cab1d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

Cough and Sore Throat Daytime
Acetaminophen, Dextromethorphan HBr
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
CARBOXYMETHYLCELLULOSE SODIUM
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
MENTHOL
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
SORBITOL
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61715-076	61715-076-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MENTHOL	L7T10EIP3A	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
SUCROSE	C151H8M554	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 435 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3399 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, EXTENDED RELEASE / ORAL		933 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		62 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAMUSCULAR		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAVITREAL	0.5 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c7580fe0-12e4-4daa-895e-37874adb8a4d			ba17b25c-fc4d-4673-82a3-49ab07cab1d9	2025-05-29	Warnings	Exact identifier spl set id: ba17b25c-fc4d-4673-82a3-49ab07cab1d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.