Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid
- Manufacturer
- WALGREENS | Time Cap Laboratories, Inc. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-06-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-06-11 05:11:20
Label at a glance#
ProductAcetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure3 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Daytime Pain Reliever
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 30 mL)
Acetaminophen 1000 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever
INDICATIONS & USAGE SECTION
Uses for the temporary relief of minor aches and pains associated with:
- sore throat
- headache
- muscular aches
- backache
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 3 doses (30 mL each) 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 use 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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- take only as directed
- do not exceed 3 doses (30 mL each) per day (24 hours)
- only use the dose cup provided
| adults & children 12 yrs & over | 30 mL every 6 hours |
| children under 12 yrs | ask a doctor |
OTHER SAFETY INFORMATION
Other information
- each 30 mL contains: sodium 39 mg
- do not exceed 25°C and do not refrigerate.
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, polysorbate 20, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
Nighttime Pain Reliever and Sleep Aid
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 30 mL)
Acetaminophen 1000 mg
Diphenhydramine HCl 50 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever
Nighttime sleep-aid
INDICATIONS & USAGE SECTION
Uses
- for the temporary relief of minor aches and pains associated with accompanying sleeplessness.
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 3 doses (30 mL each) 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 use 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.
OTC - DO NOT USE SECTION
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.
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of serious underlying medical illness.
These could be signs of a serious condition.
OTC - WHEN USING SECTION
When using this product
- avoid alcoholic beverages
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- take only one dose (30 mL) per day (24 hours)
- only use the dose cup provided
- only use as directed
| adults & children 12 yrs & over | 30 mL at bedtime |
| children under 12 yrs | do not use |
OTHER SAFETY INFORMATION
Other information
- each 30 mL contains: sodium 39 mg
- do not exceed 25°C and do not refrigerate.
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
670L Pain Reliever label
671L Pain Reliever + Sleep Aid label
672L Pain Reliever & Pain Reliever + Nighttime Sleep Aid Carton
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid
- Acetaminophen, Diphenhydramine HCl
- Acetaminophen Liquid
- Acetaminophen
- SODIUM CHLORIDE
- PROPYLENE GLYCOL
- XANTHAN GUM
- GLYCERIN
- SODIUM BENZOATE
- SACCHARIN SODIUM
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SORBITOL
- POLYSORBATE 20
- ANHYDROUS CITRIC ACID
- WATER
- SODIUM CITRATE, UNSPECIFIED FORM
- FD&C RED NO. 40
- SUCRALOSE
- Acetaminophen Diphenhydramine HCl Liquid
- FD&C BLUE NO. 1
- SORBITOL SOLUTION
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-8757 | 0363-8757-02 |
| 0363-6718 | 0363-6718-01 |
| 0363-6719 | 0363-6719-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-10-09 | full-release | 2026-06-01 01:22:57 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALGREENS | 40b4fe91-b1dd-147c-e063-6294a90a807d | 2026-06-09 | Warnings | 0363-6719-01 0363-6718-01 0363-8757-02 0363-8757 00363875702 00363671801 00363671901 53cf7970-d626-ee33-e063-6394a90a85b2 40b4fe91-b1dd-147c-e063-6294a90a807d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.